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.

3028
Total
3018
Cleared
90d
Avg (2y)
1976
Since
2046 Toxicology devices
351–375 of 2046
Cleared Nov 03, 2003
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · Lin-Zhi International, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 59d
Cleared Oct 10, 2003
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797 · Lin-Zhi International, Inc.
DJR · Enzyme Immunoassay, Methadone · 122d
Cleared Oct 10, 2003
ONLINE TDM AMIKA
K032279 · Roche Diagnostics Corp.
KLP · Amikacin Serum Assay · 78d
Cleared Oct 09, 2003
MAS PAR TDM
K032826 · Medical Analysis Systems, Inc.
DIF · Drug Mixture Control Materials · 29d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · Dade Behring, Inc.
DKB · Calibrators, Drug Mixture · 47d
Cleared Oct 03, 2003
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · Lin-Zhi International, Inc.
DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · 53d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902 · Roche Diagnostics Corp.
KLT · Enzyme Immunoassay, Carbamazepine · 89d
Cleared Sep 15, 2003
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
K023837 · Princeton BioMeditech Corp.
LAF · Gas Chromatography, Methamphetamine · 301d
Cleared Sep 05, 2003
BENZODIAZEPINE ENZYME IMMUNOASSAY
K032365 · Lin-Zhi International, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 36d
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 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 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · Medical Analysis Systems, Inc.
DKC · Alcohol Control Materials · 60d
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 Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · Beckman Coulter, Inc.
DJG · Enzyme Immunoassay, Opiates · 29d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · Roche Diagnostics Corp.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 77d
Cleared Apr 14, 2003
AT HOME DRUG CUP, MODEL 9150X
K030447 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 62d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · Roche Diagnostics Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 80d
Cleared Apr 03, 2003
PRECISET DAT AMPHETAMINE
K030826 · Quantimetrix Corp.
DIJ · Lead, Delta Amino Levulinic Acid · 20d

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All categories 2046 DJG Enzyme Immunoassay, Opiates 122 DIF Drug Mixture Control Materials 104 DKZ Enzyme Immunoassay, Amphetamine 103 DLJ Calibrators, Drug Specific 84 LDJ Enzyme Immunoassay, Cannabinoids 78 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 72 DKB Calibrators, Drug Mixture 68 JXM Enzyme Immunoassay, Benzodiazepine 66 DIS Enzyme Immunoassay, Barbiturate 65 KXT Enzyme Immunoassay, Digoxin 50 LAS Drug Specific Control Materials 49 LCM Enzyme Immunoassay, Phencyclidine 48 DJR Enzyme Immunoassay, Methadone 45 KLS Enzyme Immunoassay, Theophylline 41 DIP Enzyme Immunoassay, Diphenylhydantoin 32