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Code of Federal Regulations (Last Updated: January 31, 2019) |
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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 display. |
| § 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. |
| § 862.1625 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. |
| § 862.1678 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. |
| § 862.2140 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. |
| § 862.3250 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. |
Authority
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source
52 FR 16122, May 1, 1987, unless otherwise noted.
EditorNote
, Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.