FDA 21 CFR Part 862 Clinical Chemistry and Clinical Toxicology Devices:

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Table of contents

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.

862.1230 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.

862.1358 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, and...

Subpart C - Clinical Laboratory Instruments, (and)

Subpart D - Clinical Toxicology Test Systems

FDA 21 CFR Part 862 Clinical Chemistry and Clinical Toxicology Devices: