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
576–600 of 3029
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · Microgenics Corp.
DJR · Enzyme Immunoassay, Methadone · 302d
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049 · Roche Diagnostics Corp.
LEG · Enzyme Immunoassay, Valproic Acid · 51d
Cleared Aug 21, 2003
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
K032057 · Branan Medical Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 50d
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 54d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · Roche Diagnostics Corp.
DKB · Calibrators, Drug Mixture · 51d
Cleared Aug 04, 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
K031759 · ACON Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 59d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · Dade Behring, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 70d
Cleared Jul 15, 2003
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · Clinical Data, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 105d
Cleared Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · Beckman Coulter, Inc.
LEG · Enzyme Immunoassay, Valproic Acid · 28d
Cleared Jul 14, 2003
VERDICT II, PROFILE II
K031032 · Medtox Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 104d
Cleared Jul 11, 2003
A/C ENZYMATIC HOMOCYSTEINE ASSAY
K030754 · Anticancer, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 123d
Cleared Jul 02, 2003
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
K030113 · Branan Medical Corp.
DJG · Enzyme Immunoassay, Opiates · 170d
Cleared Jul 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · Medical Analysis Systems, Inc.
DKC · Alcohol Control Materials · 60d
Cleared Jun 13, 2003
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
K030211 · Icn Biomedicals, Inc.
DKX · Thin Layer Chromatography, Barbiturate · 143d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · Dade Behring, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 67d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · Microgenics Corp.
MRS · Test System, Nicotine, Cotinine, Metabolites · 83d
Cleared May 22, 2003
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · American Bio Medica Corp.
JXN · Enzyme Immunoassay, Propoxyphene · 66d
Cleared May 14, 2003
COZART EIA COTININE URINE KIT
K021944 · Cozart Bioscience , Ltd.
MKU · Enzyme Immunoassay, Nicotine And Nicotine Metabolites · 335d
Cleared May 06, 2003
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
K023648 · Sun Biomedical Laboratories, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 188d
Cleared Apr 30, 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869 · American Bio Medica Corp.
DJR · Enzyme Immunoassay, Methadone · 161d
Not Cleared Apr 30, 2003
NIOX ARTICLE NO: 02-1000
DEN030001 · Aerocrine AB
MXA · System, Test, Breath Nitric Oxide · 43d
Cleared Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · Beckman Coulter, Inc.
DJG · Enzyme Immunoassay, Opiates · 29d
Cleared Apr 28, 2003
COZART EIA COCAINE ORAL FLIUD KIT
K030234 · Cozart Bioscience , Ltd.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 95d
Cleared Apr 28, 2003
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
K030405 · Seradyn
LEG · Enzyme Immunoassay, Valproic Acid · 81d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · Roche Diagnostics Corp.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 77d

Looking for a specific toxicology device? Search by device name, K-number or manufacturer.

Search all Toxicology 510(k) devices

Filter by Product Code

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