cfr_sections
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259 rows where agency = "FDA" and part_number = 862 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:8.0.1.1.18.1.1.1 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | A | Subpart A—General Provisions | § 862.1 Scope. | FDA | [52 FR 16122, May 1, 1987, as amended at 67 FR 58329, Sept. 16, 2002; 78 FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014] | (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required in § 807.87. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (d) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. | |||
| 21:21:8.0.1.1.18.1.1.2 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | A | Subpart A—General Provisions | § 862.2 Regulation of calibrators. | FDA | Many devices classified in this part are intended to be used with a calibrator. A calibrator has a reference value assigned to it which serves as the basis by which test results of patients are derived or calculated. The calibrator for a device may be (a) manufactured and distributed separately from the device with which it is intended to be used, (b) manufactured and distributed as one of several device components, such as in a kit of reagents, or (c) built-in as an integral part of the device. Because of the central role that a calibrator plays in the measurement process and the critical effect calibrators have on accuracy of test results, elsewhere in this part, all three of these types of calibrators (§§ 862.1150 and 862.3200 of this part) are classified into class II, notwithstanding the classification of the device with which it is intended to be used. Thus, a device and its calibrator may have different classifications, even if the calibrator is built into the device. | ||||
| 21:21:8.0.1.1.18.1.1.3 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | A | Subpart A—General Provisions | § 862.3 Effective dates of requirement for premarket approval. | FDA | A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PM… | ||||
| 21:21:8.0.1.1.18.1.1.4 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | A | Subpart A—General Provisions | § 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). | FDA | [65 FR 2304, Jan. 14, 2000] | The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chroni… | |||
| 21:21:8.0.1.1.18.2.1.1 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1020 Acid phosphatase (total or prostatic) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] | (a) Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.10 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1065 Ammonia test system. | FDA | (a) Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome. (b) Classification. Class I. | ||||
| 21:21:8.0.1.1.18.2.1.100 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1470 Lipid (total) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.101 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1475 Lipoprotein test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.102 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1485 Luteinizing hormone test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.103 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1488 Lysosomal storage disorder newborn screening test system. | FDA | [90 FR 27230, June 26, 2025] | (a) Identification. A lysosomal storage disorder newborn screening test system is intended to measure lysosomal enzyme levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for a lysosomal storage disorder. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include information that demonstrates the performance characteristics of the device, including: (i) Study results that adequately demonstrate the clinical validity of the device, which must include information supporting the link between the analyte being measured and the condition being screened. The clinical validity of the device must be demonstrated in a clinical validation study using either well-characterized prospectively or retrospectively obtained clinical specimens from the intended use population. Testing in the clinical validation study must be performed by operators representative of the types of operators intended to use the test. The study design of the clinical validation study must assess the effects of sample collection and processing steps on test performance. Confirmed positive specimens must have a diagnosis based on confirmatory diagnostic methods or clinically meaningful information regarding the status of the subject must be obtained. (ii) The reference interval in the normal newborn population for the analyte or analytes measured by the device. (iii) Study results demonstrating the level of carryover or drift affecting the device performance. (iv) Study results demonstrating the concentrations of the limit of blank, limit of detection, and limit of quantitation of the device. Sample concentrations below the limit of quantitation must not be reported by the device. (v) Study results, which must be collected using sample panels from at least three reagent lots and at least three instruments over more than 20 testing days, demonstrating the imprecision of the device. The sample panels must … | |||
| 21:21:8.0.1.1.18.2.1.104 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1490 Lysozyme (muramidase) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme lysozyme (muramidase) in serum, plasma, leukocytes, and urine. Lysozyme measurements are used in the diagnosis and treatment of monocytic leukemia and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.105 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1493 Breast milk macronutrients test system. | FDA | [90 FR 19628, May 9, 2025] | (a) Identification. A breast milk macronutrients test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include the following: (i) An appropriate traceability plan, as determined by FDA, to minimize the risk of drift in the breast milk macronutrient test system results over time. (ii) Data that demonstrate appropriate precision, as determined by FDA, of the breast milk macronutrients test system. Precision studies must include assessment of a minimum of three breast milk specimens containing different concentrations (low, medium, and high levels) of fat, carbohydrates, and protein. Precision data must include breast milk specimen measurements that are collected at a minimum of three laboratory sites. (iii) Data that demonstrate appropriate measurement accuracy, as determined by FDA, of fat, carbohydrates, and protein in breast milk. Measurement accuracy data must include breast milk specimen measurements that are collected at a minimum of one laboratory site. (iv) Data from studies appropriate, as determined by FDA, to demonstrate that the device is free from significant interference from substances that could be present in human milk, including hemoglobin, and medications that are used by breastfeeding subjects. (2) The labeling required under § 809.10 of this chapter must include a limiting statement indicating that the results should be used only as an aid in the nutritional management of infants and not as the sole basis for making nutrition decisions. | |||
| 21:21:8.0.1.1.18.2.1.106 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1495 Magnesium test system. | FDA | (a) Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). (b) Classification. Class I. | ||||
| 21:21:8.0.1.1.18.2.1.107 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1500 Malic dehydrogenase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A malic dehydrogenase test system is a device that is intended to measure the activity of the enzyme malic dehydrogenase in serum and plasma. Malic dehydrogenase measurements are used in the diagnosis and treatment of muscle and liver diseases, myocardial infarctions, cancer, and blood disorders such as myelogenous (produced in the bone marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.108 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1505 Mucopolysaccharides (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urine. Mucopolysaccharide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.109 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1506 Muscular dystrophy newborn screening test. | FDA | [90 FR 27228, June 26, 2025] | (a) Identification. A muscular dystrophy newborn screening test is an in vitro diagnostic device intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include a clinical validation study that includes the following: (i) Results that demonstrate that the analyte being measured identifies a population of newborns who should be subject to follow up diagnostic testing for the condition being screened. (ii) Predictive value of the device demonstrated using either well characterized prospectively or retrospectively obtained clinical specimens from the intended use population. (iii) Testing performed by device users who are representative of the types of operators intended to use the test. (iv) A design that assesses the effects of sample collection and processing steps on test performance. (v) Tested confirmed positive specimens must have associated diagnostic outcome information based on confirmatory diagnostic methods, or clinically meaningful information regarding the status of the subject must be obtained. (vi) Data, provided or referenced, generated in samples from the intended use population, that demonstrates the upper reference interval(s), including sufficient samples to calculate the 97.5th and 99.5th percentile information, for the analyte or analytes measured by the device. (2) The labeling required under § 809.10(b) of this chapter must include: (i) A warning which states that test results are not intended to diagnose muscular dystrophies. (ii) A warning which states that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, and clinical evaluation as appropriate. (iii) Detailed information on device perf… | |||
| 21:21:8.0.1.1.18.2.1.11 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1070 Amylase test system. | FDA | (a) Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.110 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1509 Methylmalonic acid (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] | (a) Identification. A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identification of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonic aciduria, a heritable metabolic disorder which, if untreated, may cause mental retardation. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.111 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1510 Nitrite (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.112 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1515 Nitrogen (amino-nitrogen) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.113 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1520 5′-Nucleotidase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A 5′-nucleotidase test system is a device intended to measure the activity of the enzyme 5′-nucleotidase in serum and plasma. Measurements of 5′-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.114 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1530 Plasma oncometry test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A plasma oncometry test system is a device intended to measure plasma oncotic pressure. Plasma oncotic pressure is that portion of the total fluid pressure contributed by proteins and other molecules too large to pass through a specified membrane. Measurements of plasma oncotic pressure are used in the diagnosis and treatment of dehydration and circulatory disorders related to low serum protein levels and increased capillary permeability, such as edema and shock. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.115 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1535 Ornithine carbamyl transferase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. An ornithine carbamyl transferase test system is a device intended to measure the activity of the enzyme ornithine carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase measurements are used in the diagnosis and treatment of liver diseases, such as infectious hepatitis, acute cholecystitis (inflammation of the gall bladder), cirrhosis, and liver metastases. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.116 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1540 Osmolality test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.117 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1542 Oxalate test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.118 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1545 Parathyroid hormone test system. | FDA | (a) Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.119 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1550 Urinary pH (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.12 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1075 Androstenedione test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.120 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1555 Phenylalanine test system. | FDA | (a) Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.121 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1560 Urinary phenylketones (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.122 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1565 6-Phosphogluconate dehydrogenase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A 6-phosphogluconate dehydrogenase test system is a device intended to measure the activity of the enzyme 6-phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. Measurements of 6-phosphogluconate dehydrogenase are used in the diagnosis and treatment of certain liver diseases (such as hepatitis) and anemias. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.123 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1570 Phosphohexose isomerase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme phosphohexose isomerase in serum. Measurements of phosphohexose isomerase are used in the diagnosis and treatment of muscle diseases such as muscular dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic carcinoma. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.124 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1575 Phospholipid test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.125 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1580 Phosphorus (inorganic) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] | (a) Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.126 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1585 Human placental lactogen test system. | FDA | (a) Identification. A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.127 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1590 Porphobilinogen test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] | (a) Identification. A porphobilinogen test system is a device intended to measure porphobilinogen (one of the derivatives of hemoglobin which can make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrine metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.128 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1595 Porphyrins test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.129 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1600 Potassium test system. | FDA | (a) Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.13 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1080 Androsterone test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.130 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1605 Pregnanediol test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.131 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1610 Pregnanetriol test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A pregnanetriol test system is a device intended to measure pregnanetriol (a precursor in the biosynthesis of the adrenal hormone cortisol) in urine. Measurements obtained by this device are used in the diagnosis and treatment of congenital adrenal hyperplasia (congenital enlargement of the adrenal gland). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.132 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1615 Pregnenolone test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A pregnenolone test system is a device intended to measure pregnenolone (a precursor in the biosynthesis of the adrenal hormone cortisol and adrenal androgen) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases of the adrenal cortex or the gonads. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.133 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1620 Progesterone test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.134 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1622 Prognostic test for assessment of liver related disease progression. | FDA | [88 FR 2519, Jan. 17, 2023] | (a) Identification. A prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include clinical validation data providing: (i) Information demonstrating clinical performance in a population of patients with liver disease for the different risk categories ( e.g., at lower risk, at higher risk) for progression of their disease using well characterized clinical specimens representing the intended use population collected from multiple intended clinical sites, or an alternative study design determined to be appropriate by FDA. (ii) Information demonstrating that the outcomes measured and the length of followup are clinically relevant for the progression of the specified liver disease. (iii) Information demonstrating that the clinical criteria for determining whether the target disease is present and that the exclusion and inclusion criteria for subjects who have the target disease are appropriate. (iv) Information demonstrating test performance of the complete test system, including any sample collection and processing steps. (v) Information, provided or referenced, generated in samples from non-diseased individuals, that demonstrate the upper and lower reference intervals for the output provided by the device. (2) The labeling required under 21 CFR 809.10(b) must include: (i) A warning statement that test results are not intended to diagnose disease or for monitoring the effect of any therapeutic p… | |||
| 21:21:8.0.1.1.18.2.1.135 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1625 Prolactin (lactogen) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.136 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1630 Protein (fractionation) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.137 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1635 Total protein test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998] | (a) Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.138 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1640 Protein-bound iodine test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.139 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1645 Urinary protein or albumin (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.14 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1085 Angiotensin I and renin test system. | FDA | (a) Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.140 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1650 Pyruvate kinase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells). Measurements obtained by this device are used in the diagnosis and treatment of various inherited anemias due to pyruvate kinase deficiency or of acute leukemias. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.141 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1655 Pyruvic acid test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A pyruvic acid test system is a device intended to measure pyruvic acid (an intermediate compound in the metabolism of carbohydrate) in plasma. Measurements obtained by this device are used in the evaluation of electrolyte metabolism and in the diagnosis and treatment of acid-base and electrolyte disturbances or anoxia (the reduction of oxygen in body tissues). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.142 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1660 Quality control material (assayed and unassayed). | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 FR 71796, Dec. 30, 2019] | (a) Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. (b) Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.143 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1665 Sodium test system. | FDA | (a) Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.144 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1670 Sorbitol dehydrogenase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders such as cirrhosis or acute hepatitis. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.145 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1675 Blood specimen collection device. | FDA | (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.146 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1676 Blood collection device for cell-free nucleic acids. | FDA | [89 FR 72983, Sept. 9, 2024] | (a) Identification. A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device for its intended use, including all of its indications for use, and must include the following: (i) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( e.g., validated device design features and specifications) to ensure that users of blood collection device for cell-free nucleic acids devices are not exposed to undue risk of bloodborne pathogen exposure and operator injury during use of the device, including blood collection, transportation, and centrifugation processes. (ii) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( e.g., validated device design features and specifications) to ensure that the device reproducibly and reliably collects, transports, stabilizes, and isolates cell-free nucleic acids of sufficient yield and quality suitable for downstream applications as appropriate for its intended use. At a minimum, these measures must include: (A) Data demonstrating that blood samples collected in the device have reproducible cell-free nucleic acid yields that are suitable, as determined by FDA, for downstream testing as appropriate for the intended use, including estimates of within-lot, within-device, and lot-to-lot variability; (B) Data demonstrating that cell-free nucleic acid yields isolated from blood specimens collected into the device do not add clinically significant bias to test results obtained using the downstream application(s) described in the intended use. For devices indicated for use… | |||
| 21:21:8.0.1.1.18.2.1.147 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1678 Tacrolimus test system. | FDA | [67 FR 58329, Sept. 16, 2002] | (a) Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus. (b) Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document. | |||
| 21:21:8.0.1.1.18.2.1.148 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1680 Testosterone test system. | FDA | [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988] | (a) Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes. (b) Classification. Class I. | |||
| 21:21:8.0.1.1.18.2.1.149 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1685 Thyroxine-binding globulin test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] | (a) Identification. A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.15 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1090 Angiotensin converting enzyme (A.C.E.) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] | (a) Identification. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.150 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1690 Thyroid stimulating hormone test system. | FDA | (a) Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.151 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1695 Free thyroxine test system. | FDA | (a) Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.152 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1700 Total thyroxine test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019] | (a) Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.153 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1705 Triglyceride test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.154 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1710 Total triiodothyronine test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 62286, Oct. 18, 2000] | (a) Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. (b) Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.155 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1715 Triiodothyronine uptake test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 64 FR 1124, Jan. 8, 1999] | (a) Identification. A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. (b) Classification. Class II. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.156 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1720 Triose phosphate isomerase test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A triose phosphate isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis (the energy-yielding conversion of glucose to lactic acid in various tissues). Measurements obtained by this device are used in the diagnosis and treatment of congenital triose phosphate isomerase enzyme deficiency, which causes a type of hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.157 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1725 Trypsin test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.158 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1730 Free tyrosine test system. | FDA | (a) Identification. A free tyrosine test system is a device intended to measure free tyrosine (an amono acid) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia (a disease that can cause liver/kidney disorders) and as an adjunct to the measurement of phenylalanine in detecting congenital phenylketonuria (a disease that can cause brain damage). (b) Classification. Class I. | ||||
| 21:21:8.0.1.1.18.2.1.159 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1770 Urea nitrogen test system. | FDA | (a) Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.16 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1092 Anti-mullerian hormone test system. | FDA | [90 FR 22850, May 30, 2025] | (a) Identification. An anti-mullerian hormone test system is an in vitro diagnostic device intended to measure anti-mullerian hormone in human serum and plasma. An anti-mullerian hormone test system is intended to be used for assessing ovarian reserve in women. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include: (i) An adequate traceability plan to minimize the risk of drift in anti-mullerian hormone test system results over time. (ii) Detailed documentation of a prospective clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (A) Results must demonstrate adequate clinical performance relative to a well-accepted comparator. (B) Clinical sample results must demonstrate consistency of device output throughout the device measuring range that is appropriate for the intended use population. (C) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the proposed indications for use(s), and results of all statistical analyses. (iii) Reference intervals generated by testing an adequate number of samples from apparently healthy normal individuals in the intended use population. (2) The labeling required under § 809.10(b) of this chapter must include a warning statement that the device is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy, and that the device should be used in conjunction with the antral follicle count. | |||
| 21:21:8.0.1.1.18.2.1.160 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1775 Uric acid test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020] | (a) Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. (b) Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.161 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1780 Urinary calculi (stones) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A urinary calculi (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in the diagnosis and treatment of calculi of the urinary tract. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.162 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1785 Urinary urobilinogen (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.163 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1790 Uroporphyrin test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.164 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1795 Vanilmandelic acid test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.165 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1805 Vitamin A test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A vitamin A test system is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestinal disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.166 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1810 Vitamin B | FDA | (a) Identification. A vitamin B 12 test system is a device intended to measure vitamin B 12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.167 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1815 Vitamin E test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] | (a) Identification. A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.168 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1820 Xylose test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] | (a) Identification. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.169 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1825 Vitamin D test system. | FDA | [63 FR 40366, July 29, 1998] | (a) Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency. (b) Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls: (1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards. | |||
| 21:21:8.0.1.1.18.2.1.17 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1093 Menopause test system. | FDA | [90 FR 40708, Aug. 21, 2025] | (a) Identification. A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women. (b) Classification. Class II (special controls). A menopause test system must comply with the following special controls: (1) Design verification and validation must include the following: (i) An appropriate traceability plan to minimize the risk of drift in the menopause test system results over time. (ii) Detailed documentation of a clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (A) Results must demonstrate appropriate clinical performance relative to a well-accepted and appropriate comparator. (B) Data must demonstrate accuracy of device output for each indicated specimen type throughout the device measuring range as appropriate for the intended use population. (2) The labeling required under § 809.10 of this chapter must include the following: (i) A statement in the indications for use that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions. (ii) A limiting statement that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions. (iii) A limiting statement appropriately describing the risks of false test results and that test results should not be relied upon in clinical decision making ( e.g., to discontinue contraceptive use and/or to evaluate patients for the presence of endometrial cancer) without other clinical and laboratory findings. | |||
| 21:21:8.0.1.1.18.2.1.170 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system. | FDA | [82 FR 51559, Nov. 7, 2017, as amended at 83 FR 25914, June 5, 2018] | (a) Identification. A total 25-hydroxyvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 862.9. The device must comply with the following special controls: (1) The device must have initial and annual standardization verification by a certifying vitamin D standardization organization deemed acceptable by FDA. (2) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of performance testing conducted to evaluate precision, accuracy, linearity, interference, including the following: (i) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard. (ii) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device. (iii) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-Epi-25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-Dihydroxyvitamin D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-Dihydroxyvitamin D2, and 3-Epi-1,25-Dihydroxyvitamin D3, 25, 26-Dihydroxyvitamin-D3, 24 (R), 25-dihydroxyvitamin-D3, 23 (R), 25-dihydroxyvitamin-D3 must be described in… | |||
| 21:21:8.0.1.1.18.2.1.18 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1095 Ascorbic acid test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.19 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1100 Aspartate amino transferase (AST/SGOT) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] | (a) Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.2 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1025 Adrenocorticotropic hormone (ACTH) test system. | FDA | (a) Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.20 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1110 Bilirubin (total or direct) test system. | FDA | (a) Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.21 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1113 Bilirubin (total and unbound) in the neonate test system. | FDA | [54 FR 30206, July 19, 1989] | (a) Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus). (b) Classification. Class I. | |||
| 21:21:8.0.1.1.18.2.1.22 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.23 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1117 B-type natriuretic peptide test system. | FDA | [66 FR 12734, Feb. 28, 2001] | (a) Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure. (b) Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.” | |||
| 21:21:8.0.1.1.18.2.1.24 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1118 Biotinidase test system. | FDA | [65 FR 16521, Mar. 29, 2000] | (a) Identification. The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment. (b) Classification. Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter. | |||
| 21:21:8.0.1.1.18.2.1.25 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1120 Blood gases (P | FDA | (a) Identification. A blood gases (P CO2 , P O2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (P CO2 , P O2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.26 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1130 Blood volume test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte mass and total blood volume). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.27 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1135 C-peptides of proinsulin test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.28 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1140 Calcitonin test system. | FDA | (a) Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland). (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.29 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1145 Calcium test system. | FDA | (a) Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). (b) Classification. Class II. | ||||
| 21:21:8.0.1.1.18.2.1.3 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1030 Alanine amino transferase (ALT/SGPT) test system. | FDA | [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] | (a) Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.30 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1150 Calibrator. | FDA | [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019] | (a) Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.) (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. | |||
| 21:21:8.0.1.1.18.2.1.31 | 21 | Food and Drugs | I | H | 862 | PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES | B | Subpart B—Clinical Chemistry Test Systems | § 862.1155 Human chorionic gonadotropin (HCG) test system. | FDA | (a) Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1) Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class II. (b) Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1) Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class III. (3) Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3. |
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