CFR /  Title 21  /  Part 862: Clinical Chemistry And Clinical Toxicology Devices

Section No.	Description
Section 862.1	Regulation of calibrators
Section 862.2	Effective dates of requirement for premarket approval
Section 862.3	Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
Section 862.9	Acid phosphatase (total or prostatic) test system
Section 862.1020	Adrenocorticotropic hormone (ACTH) test system
Section 862.1025	Alanine amino transferase (ALT/SGPT) test system
Section 862.1030	Albumin test system
Section 862.1035	Aldolase test system
Section 862.1040	Aldosterone test system
Section 862.1045	Alkaline phosphatase or isoenzymes test system
Section 862.1050	Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry
Section 862.1055	Delta-aminolevulinic acid test system
Section 862.1060	Ammonia test system
Section 862.1065	Amylase test system
Section 862.1070	Androstenedione test system
Section 862.1075	Androsterone test system
Section 862.1080	Angiotensin I and renin test system
Section 862.1085	Angiotensin converting enzyme (A
Section 862.1090	Ascorbic acid test system
Section 862.1095	Aspartate amino transferase (AST/SGOT) test system
Section 862.1100	Bilirubin (total or direct) test system
Section 862.1110	Bilirubin (total and unbound) in the neonate test system
Section 862.1113	Urinary bilirubin and its conjugates (nonquantitative) test system
Section 862.1115	B-type natriuretic peptide test system
Section 862.1117	Biotinidase test system
Section 862.1118	Blood gases (PCO2, PO2) and blood pH test system
Section 862.1120	Blood volume test system
Section 862.1130	C-peptides of proinsulin test system
Section 862.1135	Calcitonin test system
Section 862.1140	Calcium test system
Section 862.1145	Calibrator
Section 862.1150	Human chorionic gonadotropin (HCG) test system
Section 862.1155	Bicarbonate/carbon dioxide test system
Section 862.1160	Cardiac allograft gene expression profiling test system
Section 862.1163	Catecholamines (total) test system
Section 862.1165	Chloride test system
Section 862.1170	Cholesterol (total) test system
Section 862.1175	Cholylglycine test system
Section 862.1177	Chymotrypsin test system
Section 862.1180	Compound S (11-deoxycortisol) test system
Section 862.1185	Conjugated sulfolithocholic acid (SLCG) test system
Section 862.1187	Copper test system
Section 862.1190	Corticoids test system
Section 862.1195	Corticosterone test system
Section 862.1200	Cortisol (hydrocortisone and hydroxycorticosterone) test system
Section 862.1205	Creatine test system
Section 862.1210	Creatine phosphokinase/creatine kinase or isoenzymes test system
Section 862.1215	Creatinine test system
Section 862.1225	Cyclic AMP test system
Section 862.1230	Cyclosporine test system
Section 862.1235	Cystine test system
Section 862.1240	Dehydroepiandrosterone (free and sulfate) test system
Section 862.1245	Desoxycorticosterone test system
Section 862.1250	Estradiol test system
Section 862.1260	Estriol test system
Section 862.1265	Estrogens (total, in pregnancy) test system
Section 862.1270	Estrogens (total, nonpregnancy) test system
Section 862.1275	Estrone test system
Section 862.1280	Etiocholanolone test system
Section 862.1285	Fatty acids test system
Section 862.1290	Folic acid test system
Section 862.1295	Follicle-stimulating hormone test system
Section 862.1300	Formiminoglutamic acid (FIGLU) test system
Section 862.1305	Galactose test system
Section 862.1310	Galactose-1-phosphate uridyl transferase test system
Section 862.1315	Gastric acidity test system
Section 862.1320	Gastrin test system
Section 862.1325	Globulin test system
Section 862.1330	Glucagon test system
Section 862.1335	Urinary glucose (nonquantitative) test system
Section 862.1340	Glucose test system
Section 862.1345	Gamma-glutamyl transpeptidase and isoenzymes test system
Section 862.1360	Glutathione test system
Section 862.1365	Human growth hormone test system
Section 862.1370	Hemoglobin A1c test system
Section 862.1373	Histidine test system
Section 862.1375	Urinary homocystine (nonquantitative) test system
Section 862.1377	Hydroxybutyric dehydrogenase test system
Section 862.1380	Hydroxyproline test system
Section 862.1400	Immunoreactive insulin test system
Section 862.1405	Iron (non-heme) test system
Section 862.1410	Iron-binding capacity test system
Section 862.1415	Isocitric dehydrogenase test system
Section 862.1420	Ketones (nonquantitative) test system
Section 862.1435	Lactate dehydrogenase test system
Section 862.1440	Lactate dehydrogenase isoenzymes test system
Section 862.1445	Lactic acid test system
Section 862.1450	Lecithin/sphingomyelin ratio in amniotic fluid test system
Section 862.1455	Leucine aminopeptidase test system
Section 862.1460	Lipase test system
Section 862.1465	Lipid (total) test system
Section 862.1470	Lipoprotein test system
Section 862.1475	Luteinizing hormone test system
Section 862.1485	Lysozyme (muramidase) test system
Section 862.1490	Magnesium test system
Section 862.1495	Malic dehydrogenase test system
Section 862.1500	Mucopolysaccharides (nonquantitative) test system
Section 862.1505	Methylmalonic acid (nonquantitative) test system
Section 862.1509	Nitrite (nonquantitative) test system
Section 862.1510	Nitrogen (amino-nitrogen) test system
Section 862.1515	Plasma oncometry test system
Section 862.1530	Ornithine carbamyl transferase test system
Section 862.1535	Osmolality test system
Section 862.1540	Oxalate test system
Section 862.1542	Parathyroid hormone test system
Section 862.1545	Urinary pH (nonquantitative) test system
Section 862.1550	Phenylalanine test system
Section 862.1555	Urinary phenylketones (nonquantitative) test system
Section 862.1560	Phosphohexose isomerase test system
Section 862.1570	Phospholipid test system
Section 862.1575	Phosphorus (inorganic) test system
Section 862.1580	Human placental lactogen test system
Section 862.1585	Porphobilinogen test system
Section 862.1590	Porphyrins test system
Section 862.1595	Potassium test system
Section 862.1600	Pregnanediol test system
Section 862.1605	Pregnanetriol test system
Section 862.1610	Pregnenolone test system
Section 862.1615	Progesterone test system
Section 862.1620	Prolactin (lactogen) test system
Section 862.1625	Protein (fractionation) test system
Section 862.1630	Total protein test system
Section 862.1635	Protein-bound iodine test system
Section 862.1640	Urinary protein or albumin (nonquantitative) test system
Section 862.1645	Pyruvate kinase test system
Section 862.1650	Pyruvic acid test system
Section 862.1655	Quality control material (assayed and unassayed)
Section 862.1660	Sodium test system
Section 862.1665	Sorbitol dehydrogenase test system
Section 862.1670	Blood specimen collection device
Section 862.1675	Tacrolimus test system
Section 862.1678	Testosterone test system
Section 862.1680	Thyroxine-binding globulin test system
Section 862.1685	Thyroid stimulating hormone test system
Section 862.1690	Free thyroxine test system
Section 862.1695	Total thyroxine test system
Section 862.1700	Triglyceride test system
Section 862.1705	Total triiodothyronine test system
Section 862.1710	Triiodothyronine uptake test system
Section 862.1715	Triose phosphate isomerase test system
Section 862.1720	Trypsin test system
Section 862.1725	Free tyrosine test system
Section 862.1730	Urea nitrogen test system
Section 862.1770	Uric acid test system
Section 862.1775	Urinary calculi (stones) test system
Section 862.1780	Urinary urobilinogen (nonquantitative) test system
Section 862.1785	Uroporphyrin test system
Section 862.1790	Vanilmandelic acid test system
Section 862.1795	Vitamin A test system
Section 862.1805	Vitamin B [bdi1][bdi2] test system
Section 862.1810	Vitamin E test system
Section 862.1815	Xylose test system
Section 862.1820	Vitamin D test system
Section 862.1825	General purpose laboratory equipment labeled or promoted for a specific medical use
Section 862.2050	Calculator/data processing module for clinical use
Section 862.2100	Centrifugal chemistry analyzer for clinical use
Section 862.2140	Continuous flow sequential multiple chemistry analyzer for clinical use
Section 862.2150	Discrete photometric chemistry analyzer for clinical use
Section 862.2160	Micro chemistry analyzer for clinical use
Section 862.2170	Chromatographic separation material for clinical use
Section 862.2230	Gas liquid chromatography system for clinical use
Section 862.2250	High pressure liquid chromatography system for clinical use
Section 862.2260	Thin-layer chromatography system for clinical use
Section 862.2270	Colorimeter, photometer, or spectrophotometer for clinical use
Section 862.2300	Clinical sample concentrator
Section 862.2310	Beta or gamma counter for clinical use
Section 862.2320	Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use
Section 862.2400	Electrophoresis apparatus for clinical use
Section 862.2485	Enzyme analyzer for clinical use
Section 862.2500	Flame emission photometer for clinical use
Section 862.2540	Fluorometer for clinical use
Section 862.2560	Instrumentation for clinical multiplex test systems
Section 862.2570	Microtitrator for clinical use
Section 862.2680	Nephelometer for clinical use
Section 862.2700	Plasma oncometer for clinical use
Section 862.2720	Osmometer for clinical use
Section 862.2730	Pipetting and diluting system for clinical use
Section 862.2750	Refractometer for clinical use
Section 862.2800	Atomic absorption spectrophotometer for clinical use
Section 862.2850	Mass spectrometer for clinical use
Section 862.2860	Automated urinalysis system
Section 862.2900	Plasma viscometer for clinical use
Section 862.2920	Acetaminophen test system
Section 862.3030	Amikacin test system
Section 862.3035	Alcohol test system
Section 862.3040	Breath-alcohol test system
Section 862.3050	Breath nitric oxide test system
Section 862.3080	Amphetamine test system
Section 862.3100	Antimony test system
Section 862.3110	Arsenic test system
Section 862.3120	Barbiturate test system
Section 862.3150	Benzodiazepine test system
Section 862.3170	Clinical toxicology calibrator
Section 862.3200	Carbon monoxide test system
Section 862.3220	Cholinesterase test system
Section 862.3240	Cocaine and cocaine metabolite test system
Section 862.3250	Codeine test system
Section 862.3270	Clinical toxicology control material
Section 862.3280	Digitoxin test system
Section 862.3300	Digoxin test system
Section 862.3320	Diphenylhydantoin test system
Section 862.3350	Drug metabolizing enzyme genotyping system
Section 862.3360	Ethosuximide test system
Section 862.3380	Gentamicin test system
Section 862.3450	Kanamycin test system
Section 862.3520	Lead test system
Section 862.3550	Lidocaine test system
Section 862.3555	Lithium test system
Section 862.3560	Lysergic acid diethylamide (LSD) test system
Section 862.3580	Mercury test system
Section 862.3600	Methamphetamine test system
Section 862.3610	Methadone test system
Section 862.3620	Methaqualone test system
Section 862.3630	Morphine test system
Section 862.3640	Neuroleptic drugs radioreceptor assay test system
Section 862.3645	Opiate test system
Section 862.3650	Phenobarbital test system
Section 862.3660	Phenothiazine test system
Section 862.3670	Primidone test system
Section 862.3680	Propoxyphene test system
Section 862.3700	Quinine test system
Section 862.3750	Salicylate test system
Section 862.3830	Sirolimus test system
Section 862.3840	Sulfonamide test system
Section 862.3850	Cannabinoid test system
Section 862.3870	Theophylline test system
Section 862.3880	Tobramycin test system
Section 862.3900	Tricyclic antidepressant drugs test system
Section 862.3910	Vancomycin test system
Section 862.3950	Scope