FDA medical devices classification list

ITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Regulation of calibrators.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Acid phosphatase (total or prostatic) test system.
    - Adrenocorticotropic hormone (ACTH) test system.
    - Alanine amino transferase (ALT/SGPT) test system.
    - Albumin test system.
    - Aldolase test system.
    - Aldosterone test system.
    - Alkaline phosphatase or isoenzymes test system.
    - Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
    - Delta-aminolevulinic acid test system.
    - Ammonia test system.
    - Amylase test system.
    - Androstenedione test system.
    - Androsterone test system.
    - Angiotensin I and renin test system.
    - Angiotensin converting enzyme (A.C.E.) test system.
    - Ascorbic acid test system.
    - Aspartate amino transferase (AST/SGOT) test system.
    - Bilirubin (total or direct) test system.
    - Bilirubin (total and unbound) in the neonate test system.
    - Urinary bilirubin and its conjugates (nonquantitative) test system.
    - B-type natriuretic peptide test system.
    - Biotinidase test system.
    - Blood gases (PCO2, PO2) and blood pH test system.
    - Blood volume test system.
    - C-peptides of proinsulin test system.
    - Calcitonin test system.
    - Calcium test system.
    - Calibrator.
    - Human chorionic gonadotropin (HCG) test system.
    - Bicarbonate/carbon dioxide test system.
    - Cardiac allograft gene expression profiling test system.
    - Catecholamines (total) test system.
    - Chloride test system.
    - Cholesterol (total) test system.
    - Cholylglycine test system.
    - Chymotrypsin test system.
    - Compound S (11-deoxycortisol) test system.
    - Conjugated sulfolithocholic acid (SLCG) test system.
    - Copper test system.
    - Corticoids test system.
    - Corticosterone test system.
    - Cortisol (hydrocortisone and hydroxycorticosterone) test system.

   - Creatine test system.
    - Creatine phosphokinase/creatine kinase or isoenzymes test system.
    - Acute kidney injury test system.
    - Creatinine test system.
    - Cyclic AMP test system.
    - Cyclosporine test system.
    - Cystine test system.
    - Dehydroepiandrosterone (free and sulfate) test system.
    - Desoxycorticosterone test system.
    - 2,3-Diphosphoglyceric acid test system.
    - Estradiol test system.
    - Estriol test system.
    - Estrogens (total, in pregnancy) test system.
    - Estrogens (total, nonpregnancy) test system.
    - Estrone test system.
    - Etiocholanolone test system.
    - Fatty acids test system.
    - Folic acid test system.
    - Follicle-stimulating hormone test system.
    - Formiminoglutamic acid (FIGLU) test system.
    - Galactose test system.
    - Galactose-1-phosphate uridyl transferase test system.
    - Gastric acidity test system.
    - Gastrin test system.
    - Globulin test system.
    - Glucagon test system.
    - Urinary glucose (nonquantitative) test system.
    - Glucose test system.
    - Continuous glucose monitor secondary alarm system.
    - Integrated continuous glucose monitoring system.
    - Interoperable automated glycemic controller.
    - Insulin therapy adjustment device.
    - Gamma-glutamyl transpeptidase and isoenzymes test system.
    - Glutathione test system.
    - Human growth hormone test system.
    - Hemoglobin A1c test system.
    - Histidine test system.
    - Urinary homocystine (nonquantitative) test system.
    - Hydroxybutyric dehydrogenase test system.
    - 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
    - 5-Hydroxyindole acetic acid/serotonin test system.
    - 17-Hydroxyprogesterone test system.
    - Hydroxyproline test system.
    - Immunoreactive insulin test system.

   - Iron (non-heme) test system.
    - Iron-binding capacity test system.
    - Isocitric dehydrogenase test system.
    - 17-Ketosteroids test system.
    - Ketones (nonquantitative) test system.
    - Lactate dehydrogenase test system.
    - Lactate dehydrogenase isoenzymes test system.
    - Lactic acid test system.
    - Lecithin/sphingomyelin ratio in amniotic fluid test system.
    - Leucine aminopeptidase test system.
    - Lipase test system.
    - Lipid (total) test system.
    - Lipoprotein test system.
    - Luteinizing hormone test system.
    - Lysozyme (muramidase) test system.
    - Magnesium test system.
    - Malic dehydrogenase test system.
    - Mucopolysaccharides (nonquantitative) test system.
    - Methylmalonic acid (nonquantitative) test system.
    - Nitrite (nonquantitative) test system.
    - Nitrogen (amino-nitrogen) test system.
    - 5'-Nucleotidase test system.
    - Plasma oncometry test system.
    - Ornithine carbamyl transferase test system.
    - Osmolality test system.
    - Oxalate test system.
    - Parathyroid hormone test system.
    - Urinary pH (nonquantitative) test system.
    - Phenylalanine test system.
    - Urinary phenylketones (nonquantitative) test system.
    - 6-Phosphogluconate dehydrogenase test system.
    - Phosphohexose isomerase test system.
    - Phospholipid test system.
    - Phosphorus (inorganic) test system.
    - Human placental lactogen test system.
    - Porphobilinogen test system.
    - Porphyrins test system.
    - Potassium test system.
    - Pregnanediol test system.
    - Pregnanetriol test system.
    - Pregnenolone test system.
    - Progesterone test system.
    - Prolactin (lactogen) test system.
    - Protein (fractionation) test system.

    - Total protein test system.
    - Protein-bound iodine test system.
    - Urinary protein or albumin (nonquantitative) test system.
    - Pyruvate kinase test system.
    - Pyruvic acid test system.
    - Quality control material (assayed and unassayed).
    - Sodium test system.
    - Sorbitol dehydrogenase test system.
    - Blood specimen collection device.
    - Tacrolimus test system.
    - Testosterone test system.
    - Thyroxine-binding globulin test system.
    - Thyroid stimulating hormone test system.
    - Free thyroxine test system.
    - Total thyroxine test system.
    - Triglyceride test system.
    - Total triiodothyronine test system.
    - Triiodothyronine uptake test system.
    - Triose phosphate isomerase test system.
    - Trypsin test system.
    - Free tyrosine test system.
    - Urea nitrogen test system.
    - Uric acid test system.
    - Urinary calculi (stones) test system.
    - Urinary urobilinogen (nonquantitative) test system.
    - Uroporphyrin test system.
    - Vanilmandelic acid test system.
    - Vitamin A test system.
    - Vitamin B12 test system.
    - Vitamin E test system.
    - Xylose test system.
    - Vitamin D test system.
    - Total 25-hydroxyvitamin D mass spectrometry test system.

    - General purpose laboratory equipment labeled or promoted for a specific medical use.
    - Calculator/data processing module for clinical use.
    - Continuous glucose monitor data management system.
    - Centrifugal chemistry analyzer for clinical use.
    - Continuous flow sequential multiple chemistry analyzer for clinical use.
    - Discrete photometric chemistry analyzer for clinical use.
    - Micro chemistry analyzer for clinical use.
    - Chromatographic separation material for clinical use.
    - Gas liquid chromatography system for clinical use.
    - High pressure liquid chromatography system for clinical use.

    - High throughput genomic sequence analyzer for clinical use.
    - Thin-layer chromatography system for clinical use.
    - Colorimeter, photometer, or spectrophotometer for clinical use.
    - Clinical sample concentrator.
    - Beta or gamma counter for clinical use.
    - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
    - Electrophoresis apparatus for clinical use.
    - Enzyme analyzer for clinical use.
    - Flame emission photometer for clinical use.
    - Fluorometer for clinical use.
    - Instrumentation for clinical multiplex test systems.
    - Microtitrator for clinical use.
    - Nephelometer for clinical use.
    - Plasma oncometer for clinical use.
    - Osmometer for clinical use.
    - Pipetting and diluting system for clinical use.
    - Refractometer for clinical use.
    - Atomic absorption spectrophotometer for clinical use.
    - Mass spectrometer for clinical use.
    - Automated urinalysis system.
    - Plasma viscometer for clinical use.

    - Acetaminophen test system.
    - Amikacin test system.
    - Alcohol test system.
    - Breath-alcohol test system.
    - Breath nitric oxide test system.
    - Amphetamine test system.
    - Antimony test system.
    - Arsenic test system.
    - Barbiturate test system.
    - Benzodiazepine test system.
    - Clinical toxicology calibrator.
    - Carbon monoxide test system.
    - Cholinesterase test system.
    - Cocaine and cocaine metabolite test system.
    - Codeine test system.
    - Clinical toxicology control material.
    - Digitoxin test system.
    - Digoxin test system.
    - Diphenylhydantoin test system.
    - Drug metabolizing enzyme genotyping system.
    - Ethosuximide test system.

  - Gentamicin test system.
    - Kanamycin test system.
    - Lead test system.
    - Lidocaine test system.
    - Lithium test system.
    - Lysergic acid diethylamide (LSD) test system.
    - Meprobamate test system.
    - Mercury test system.
    - Methamphetamine test system.
    - Methadone test system.
    - Methaqualone test system.
    - Morphine test system.
    - Neuroleptic drugs radioreceptor assay test system.
    - Opiate test system.
    - Organophosphate test system.
    - Phenobarbital test system.
    - Phenothiazine test system.
    - Primidone test system.
    - Propoxyphene test system.
    - Quinine test system.
    - Reagents for molecular diagnostic instrument test systems.
    - Salicylate test system.
    - Sirolimus test system.
    - Sulfonamide test system.
    - Cannabinoid test system.
    - Theophylline test system.
    - Tobramycin test system.
    - Tricyclic antidepressant drugs test system.
    - Vancomycin test system.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

Extracted from US.FDA