FDA Review Panel · TX

FDA 510(k) Toxicology Devices

FDA 510(k) Toxicology Devices - Regulatory Overview

FDA 510(k) toxicology devices include diagnostic systems for detecting drugs, poisons and toxic substances in biological samples. The FDA review panel code is TX.

Main categories:

  • Drug screening assays - urine and oral fluid panels for workplace and clinical use
  • Therapeutic drug monitoring (TDM) - immunosuppressants, antibiotics, anticonvulsants
  • Heavy metal testing - lead, mercury, arsenic and cadmium detection systems
  • Alcohol testing devices - breathalyzers and ethanol assays for clinical use

Most toxicology devices are Class II under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

3029
Total
3019
Cleared
95d
Avg (2y)
1976
Since
3029 Toxicology devices
701–725 of 3029
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9079
K013408 · Phamatech, Inc.
DJG · Enzyme Immunoassay, Opiates · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9074
K013409 · Phamatech, Inc.
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · Phamatech, Inc.
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9069
K013412 · Phamatech, Inc.
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 52d
Cleared Dec 04, 2001
RANDOX PHENYTOIN
K011393 · Randox Laboratories, Ltd.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 211d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K012483 · Ameditech, Inc.
DJG · Enzyme Immunoassay, Opiates · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
K012484 · Ameditech, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 120d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN PCP
K012582 · Ameditech, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 112d
Cleared Nov 26, 2001
RAPIDONE-ECSTASY TEST
K013180 · American Bio Medica Corp.
DJC · Thin Layer Chromatography, Methamphetamine · 63d
Cleared Nov 26, 2001
LIVESURE METHADONE SCREEN TESTS
K013796 · Pan Probe Biotech, Inc.
DJR · Enzyme Immunoassay, Methadone · 11d
Cleared Nov 20, 2001
'RAPIDONE'-METHADONE TEST
K012164 · American Bio Medica Corp.
DJR · Enzyme Immunoassay, Methadone · 132d
Cleared Nov 16, 2001
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
K012585 · Ameditech, Inc.
LAF · Gas Chromatography, Methamphetamine · 98d
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 78d
Cleared Nov 07, 2001
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
K013124 · Branan Medical Corp.
DJJ · Fluorometry, Morphine · 49d
Cleared Nov 06, 2001
PSYCHEMEDICS RIA COCAINE ASSAY
K010868 · Psychemedics Corp.
KLN · Radioimmunoassay, Cocaine Metabolite · 228d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 101d
Cleared Oct 25, 2001
DRUGS OF ABUSE MULTI-TEST STRIP
K011952 · Microdiagnostics, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 126d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN THC
K011813 · Ameditech, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 133d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN COC
K011814 · Ameditech, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 133d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · ACON Laboratories, Inc.
DJR · Enzyme Immunoassay, Methadone · 66d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999 · Biosite Incorporated
DIF · Drug Mixture Control Materials · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · Biosite Incorporated
DIF · Drug Mixture Control Materials · 27d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp.
KXT · Enzyme Immunoassay, Digoxin · 61d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · Randox Laboratories, Ltd.
LCD · Enzyme Immunoassay, Gentamicin · 74d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 59d

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All categories 3029 DKZ Enzyme Immunoassay, Amphetamine 191 DJG Enzyme Immunoassay, Opiates 188 DIF Drug Mixture Control Materials 148 LDJ Enzyme Immunoassay, Cannabinoids 136 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 131 DLJ Calibrators, Drug Specific 108 DIS Enzyme Immunoassay, Barbiturate 95 JXM Enzyme Immunoassay, Benzodiazepine 83 DKB Calibrators, Drug Mixture 81 LCM Enzyme Immunoassay, Phencyclidine 78 LAS Drug Specific Control Materials 75 KXT Enzyme Immunoassay, Digoxin 62 DJR Enzyme Immunoassay, Methadone 56 KLS Enzyme Immunoassay, Theophylline 50 KLT Enzyme Immunoassay, Carbamazepine 43