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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
| Subpart A - General Provisions |
| § 862.1 - Scope. |
| § 862.2 - Regulation of calibrators. |
| § 862.3 - Effective dates of requirement for premarket approval. |
| § 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
| Subpart B - Clinical Chemistry Test Systems |
| § 862.1020 - Acid phosphatase (total or prostatic) test system. |
| § 862.1025 - Adrenocorticotropic hormone (ACTH) test system. |
| § 862.1030 - Alanine amino transferase (ALT/SGPT) test system. |
| § 862.1035 - Albumin test system. |
| § 862.1040 - Aldolase test system. |
| § 862.1045 - Aldosterone test system. |
| § 862.1050 - Alkaline phosphatase or isoenzymes test system. |
| § 862.1055 - Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry. |
| § 862.1060 - Delta-aminolevulinic acid test system. |
| § 862.1065 - Ammonia test system. |
| § 862.1070 - Amylase test system. |
| § 862.1075 - Androstenedione test system. |
| § 862.1080 - Androsterone test system. |
| § 862.1085 - Angiotensin I and renin test system. |
| § 862.1090 - Angiotensin converting enzyme (A.C.E.) test system. |
| § 862.1095 - Ascorbic acid test system. |
| § 862.1100 - Aspartate amino transferase (AST/SGOT) test system. |
| § 862.1110 - Bilirubin (total or direct) test system. |
| § 862.1113 - Bilirubin (total and unbound) in the neonate test system. |
| § 862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system. |
| § 862.1117 - B-type natriuretic peptide test system. |
| § 862.1118 - Biotinidase test system. |
| § 862.1120 - Blood gases (PCO2, PO2) and blood pH test system. |
| § 862.1130 - Blood volume test system. |
| § 862.1135 - C-peptides of proinsulin test system. |
| § 862.1140 - Calcitonin test system. |
| § 862.1145 - Calcium test system. |
| § 862.1150 - Calibrator. |
| § 862.1155 - Human chorionic gonadotropin (HCG) test system. |
| § 862.1160 - Bicarbonate/carbon dioxide test system. |
| § 862.1163 - Cardiac allograft gene expression profiling test system. |
| § 862.1165 - Catecholamines (total) test system. |
| § 862.1170 - Chloride test system. |
| § 862.1175 - Cholesterol (total) test system. |
| § 862.1177 - Cholylglycine test system. |
| § 862.1180 - Chymotrypsin test system. |
| § 862.1185 - Compound S (11-deoxycortisol) test system. |
| § 862.1187 - Conjugated sulfolithocholic acid (SLCG) test system. |
| § 862.1190 - Copper test system. |
| § 862.1195 - Corticoids test system. |
| § 862.1200 - Corticosterone test system. |
| § 862.1205 - Cortisol (hydrocortisone and hydroxycorticosterone) test system. |
| § 862.1210 - Creatine test system. |
| § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system. |
| § 862.1220 - Acute kidney injury test system. |
| § 862.1225 - Creatinine test system. |
| § 862.1230 - Cyclic AMP test system. |
| § 862.1235 - Cyclosporine test system. |
| § 862.1240 - Cystine test system. |
| § 862.1245 - Dehydroepiandrosterone (free and sulfate) test system. |
| § 862.1250 - Desoxycorticosterone test system. |
| § 862.1255 - 2,3-Diphosphoglyceric acid test system. |
| § 862.1260 - Estradiol test system. |
| § 862.1265 - Estriol test system. |
| § 862.1270 - Estrogens (total, in pregnancy) test system. |
| § 862.1275 - Estrogens (total, nonpregnancy) test system. |
| § 862.1280 - Estrone test system. |
| § 862.1285 - Etiocholanolone test system. |
| § 862.1290 - Fatty acids test system. |
| § 862.1295 - Folic acid test system. |
| § 862.1300 - Follicle-stimulating hormone test system. |
| § 862.1305 - Formiminoglutamic acid (FIGLU) test system. |
| § 862.1310 - Galactose test system. |
| § 862.1315 - Galactose-1-phosphate uridyl transferase test system. |
| § 862.1320 - Gastric acidity test system. |
| § 862.1325 - Gastrin test system. |
| § 862.1330 - Globulin test system. |
| § 862.1335 - Glucagon test system. |
| § 862.1340 - Urinary glucose (nonquantitative) test system. |
| § 862.1345 - Glucose test system. |
| § 862.1350 - Continuous glucose monitor secondary alarm system. |
| § 862.1355 - Integrated continuous glucose monitoring system. |
| § 862.1356 - Interoperable automated glycemic controller. |
| § 862.1358 - Insulin therapy adjustment device. |
| § 862.1360 - Gamma-glutamyl transpeptidase and isoenzymes test system. |
| § 862.1365 - Glutathione test system. |
| § 862.1370 - Human growth hormone test system. |
| § 862.1373 - Hemoglobin A1c test system. |
| § 862.1375 - Histidine test system. |
| § 862.1377 - Urinary homocystine (nonquantitative) test system. |
| § 862.1380 - Hydroxybutyric dehydrogenase test system. |
| § 862.1385 - 17-Hydroxycorticosteroids (17-ketogenic steroids) test system. |
| § 862.1390 - 5-Hydroxyindole acetic acid/serotonin test system. |
| § 862.1395 - 17-Hydroxyprogesterone test system. |
| § 862.1400 - Hydroxyproline test system. |
| § 862.1405 - Immunoreactive insulin test system. |
| § 862.1410 - Iron (non-heme) test system. |
| § 862.1415 - Iron-binding capacity test system. |
| § 862.1420 - Isocitric dehydrogenase test system. |
| § 862.1430 - 17-Ketosteroids test system. |
| § 862.1435 - Ketones (nonquantitative) test system. |
| § 862.1440 - Lactate dehydrogenase test system. |
| § 862.1445 - Lactate dehydrogenase isoenzymes test system. |
| § 862.1450 - Lactic acid test system. |
| § 862.1455 - Lecithin/sphingomyelin ratio in amniotic fluid test system. |
| § 862.1460 - Leucine aminopeptidase test system. |
| § 862.1465 - Lipase test system. |
| § 862.1470 - Lipid (total) test system. |
| § 862.1475 - Lipoprotein test system. |
| § 862.1485 - Luteinizing hormone test system. |
| § 862.1490 - Lysozyme (muramidase) test system. |
| § 862.1495 - Magnesium test system. |
| § 862.1500 - Malic dehydrogenase test system. |
| § 862.1505 - Mucopolysaccharides (nonquantitative) test system. |
| § 862.1509 - Methylmalonic acid (nonquantitative) test system. |
| § 862.1510 - Nitrite (nonquantitative) test system. |
| § 862.1515 - Nitrogen (amino-nitrogen) test system. |
| § 862.1520 - 5'-Nucleotidase test system. |
| § 862.1530 - Plasma oncometry test system. |
| § 862.1535 - Ornithine carbamyl transferase test system. |
| § 862.1540 - Osmolality test system. |
| § 862.1542 - Oxalate test system. |
| § 862.1545 - Parathyroid hormone test system. |
| § 862.1550 - Urinary pH (nonquantitative) test system. |
| § 862.1555 - Phenylalanine test system. |
| § 862.1560 - Urinary phenylketones (nonquantitative) test system. |
| § 862.1565 - 6-Phosphogluconate dehydrogenase test system. |
| § 862.1570 - Phosphohexose isomerase test system. |
| § 862.1575 - Phospholipid test system. |
| § 862.1580 - Phosphorus (inorganic) test system. |
| § 862.1585 - Human placental lactogen test system. |
| § 862.1590 - Porphobilinogen test system. |
| § 862.1595 - Porphyrins test system. |
| § 862.1600 - Potassium test system. |
| § 862.1605 - Pregnanediol test system. |
| § 862.1610 - Pregnanetriol test system. |
| § 862.1615 - Pregnenolone test system. |
| § 862.1620 - Progesterone test system. |
| § 862.1622 - Prognostic test for assessment of liver related disease progression. |
| § 862.1625 - Prolactin (lactogen) test system. |
| § 862.1630 - Protein (fractionation) test system. |
| § 862.1635 - Total protein test system. |
| § 862.1640 - Protein-bound iodine test system. |
| § 862.1645 - Urinary protein or albumin (nonquantitative) test system. |
| § 862.1650 - Pyruvate kinase test system. |
| § 862.1655 - Pyruvic acid test system. |
| § 862.1660 - Quality control material (assayed and unassayed). |
| § 862.1665 - Sodium test system. |
| § 862.1670 - Sorbitol dehydrogenase test system. |
| § 862.1675 - Blood specimen collection device. |
| § 862.1676 - Blood collection device for cell-free nucleic acids. |
| § 862.1678 - Tacrolimus test system. |
| § 862.1680 - Testosterone test system. |
| § 862.1685 - Thyroxine-binding globulin test system. |
| § 862.1690 - Thyroid stimulating hormone test system. |
| § 862.1695 - Free thyroxine test system. |
| § 862.1700 - Total thyroxine test system. |
| § 862.1705 - Triglyceride test system. |
| § 862.1710 - Total triiodothyronine test system. |
| § 862.1715 - Triiodothyronine uptake test system. |
| § 862.1720 - Triose phosphate isomerase test system. |
| § 862.1725 - Trypsin test system. |
| § 862.1730 - Free tyrosine test system. |
| § 862.1770 - Urea nitrogen test system. |
| § 862.1775 - Uric acid test system. |
| § 862.1780 - Urinary calculi (stones) test system. |
| § 862.1785 - Urinary urobilinogen (nonquantitative) test system. |
| § 862.1790 - Uroporphyrin test system. |
| § 862.1795 - Vanilmandelic acid test system. |
| § 862.1805 - Vitamin A test system. |
| § 862.1810 - Vitamin B12 test system. |
| § 862.1815 - Vitamin E test system. |
| § 862.1820 - Xylose test system. |
| § 862.1825 - Vitamin D test system. |
| § 862.1840 - Total 25-hydroxyvitamin D mass spectrometry test system. |
| Subpart C - Clinical Laboratory Instruments |
| § 862.2050 - General purpose laboratory equipment labeled or promoted for a specific medical use. |
| § 862.2100 - Calculator/data processing module for clinical use. |
| § 862.2120 - Continuous glucose monitor data management system. |
| § 862.2140 - Centrifugal chemistry analyzer for clinical use. |
| § 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use. |
| § 862.2160 - Discrete photometric chemistry analyzer for clinical use. |
| § 862.2170 - Micro chemistry analyzer for clinical use. |
| § 862.2230 - Chromatographic separation material for clinical use. |
| § 862.2250 - Gas liquid chromatography system for clinical use. |
| § 862.2260 - High pressure liquid chromatography system for clinical use. |
| § 862.2265 - High throughput genomic sequence analyzer for clinical use. |
| § 862.2270 - Thin-layer chromatography system for clinical use. |
| § 862.2300 - Colorimeter, photometer, or spectrophotometer for clinical use. |
| § 862.2310 - Clinical sample concentrator. |
| § 862.2320 - Beta or gamma counter for clinical use. |
| § 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. |
| § 862.2485 - Electrophoresis apparatus for clinical use. |
| § 862.2500 - Enzyme analyzer for clinical use. |
| § 862.2540 - Flame emission photometer for clinical use. |
| § 862.2560 - Fluorometer for clinical use. |
| § 862.2570 - Instrumentation for clinical multiplex test systems. |
| § 862.2680 - Microtitrator for clinical use. |
| § 862.2700 - Nephelometer for clinical use. |
| § 862.2720 - Plasma oncometer for clinical use. |
| § 862.2730 - Osmometer for clinical use. |
| § 862.2750 - Pipetting and diluting system for clinical use. |
| § 862.2800 - Refractometer for clinical use. |
| § 862.2850 - Atomic absorption spectrophotometer for clinical use. |
| § 862.2860 - Mass spectrometer for clinical use. |
| § 862.2900 - Automated urinalysis system. |
| § 862.2920 - Plasma viscometer for clinical use. |
| Subpart D - Clinical Toxicology Test Systems |
| § 862.3030 - Acetaminophen test system. |
| § 862.3035 - Amikacin test system. |
| § 862.3040 - Alcohol test system. |
| § 862.3050 - Breath-alcohol test system. |
| § 862.3080 - Breath nitric oxide test system. |
| § 862.3100 - Amphetamine test system. |
| § 862.3110 - Antimony test system. |
| § 862.3120 - Arsenic test system. |
| § 862.3150 - Barbiturate test system. |
| § 862.3170 - Benzodiazepine test system. |
| § 862.3200 - Clinical toxicology calibrator. |
| § 862.3220 - Carbon monoxide test system. |
| § 862.3240 - Cholinesterase test system. |
| § 862.3245 - Clozapine test system. |
| § 862.3250 - Cocaine and cocaine metabolite test system. |
| § 862.3270 - Codeine test system. |
| § 862.3280 - Clinical toxicology control material. |
| § 862.3300 - Digitoxin test system. |
| § 862.3320 - Digoxin test system. |
| § 862.3350 - Diphenylhydantoin test system. |
| § 862.3360 - Drug metabolizing enzyme genotyping system. |
| § 862.3380 - Ethosuximide test system. |
| § 862.3450 - Gentamicin test system. |
| § 862.3520 - Kanamycin test system. |
| § 862.3550 - Lead test system. |
| § 862.3555 - Lidocaine test system. |
| § 862.3560 - Lithium test system. |
| § 862.3580 - Lysergic acid diethylamide (LSD) test system. |
| § 862.3590 - Meprobamate test system. |
| § 862.3600 - Mercury test system. |
| § 862.3610 - Methamphetamine test system. |
| § 862.3620 - Methadone test system. |
| § 862.3630 - Methaqualone test system. |
| § 862.3640 - Morphine test system. |
| § 862.3645 - Neuroleptic drugs radioreceptor assay test system. |
| § 862.3650 - Opiate test system. |
| § 862.3652 - Organophosphate test system. |
| § 862.3660 - Phenobarbital test system. |
| § 862.3670 - Phenothiazine test system. |
| § 862.3680 - Primidone test system. |
| § 862.3700 - Propoxyphene test system. |
| § 862.3750 - Quinine test system. |
| § 862.3800 - Reagents for molecular diagnostic instrument test systems. |
| § 862.3830 - Salicylate test system. |
| § 862.3840 - Sirolimus test system. |
| § 862.3850 - Sulfonamide test system. |
| § 862.3870 - Cannabinoid test system. |
| § 862.3880 - Theophylline test system. |
| § 862.3900 - Tobramycin test system. |
| § 862.3910 - Tricyclic antidepressant drugs test system. |
| § 862.3950 - Vancomycin test system. |