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
626–650 of 3029
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN THC TEST
K022955 · Amedica Biotech, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN OPIATES TEST
K023047 · Amedica Biotech, Inc.
DJG · Enzyme Immunoassay, Opiates · 55d
Cleared Nov 05, 2002
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
K020920 · Cozart Bioscience , Ltd.
DJG · Enzyme Immunoassay, Opiates · 229d
Cleared Oct 24, 2002
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
K023058 · Seradyn
KXT · Enzyme Immunoassay, Digoxin · 41d
Cleared Oct 18, 2002
NICALERT
K021688 · Nymox Pharmaceutical Corporation
MRS · Test System, Nicotine, Cotinine, Metabolites · 149d
Cleared Sep 23, 2002
FERTILITE OV
K020808 · Pheromone Sciences Corp.
NGE · Test, Luteinizing Hormone (lh), Over The Counter · 195d
Cleared Aug 30, 2002
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · Alfa Scientific Designs, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 28d
Cleared Aug 21, 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · Diagnostic Products Corp.
CEW · Radioimmunoassay, Parathyroid Hormone · 15d
Cleared Aug 15, 2002
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · Lin-Zhi International, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 69d
Cleared Jul 30, 2002
VERDICT-II
K022141 · Medtox Diagnostics, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 28d
Cleared Jul 30, 2002
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
K022355 · Branan Medical Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 11d
Cleared Jul 23, 2002
'RAPIDTEC' 5A MULTIPLE DIP TEST
K021114 · American Bio Medica Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 109d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505 · Roche Diagnostics Corp.
DJR · Enzyme Immunoassay, Methadone · 68d
Cleared Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · Roche Diagnostics Corp.
DJR · Enzyme Immunoassay, Methadone · 68d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · Roche Diagnostics Corp.
LCD · Enzyme Immunoassay, Gentamicin · 130d
Cleared Jul 11, 2002
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792 · Bayer Diagnostics Corp.
LDP · Colorimetry, Acetaminophen · 122d
Cleared Jul 11, 2002
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020794 · Bayer Diagnostics Corp.
DKJ · Colorimetry, Salicylate · 122d
Cleared Jun 18, 2002
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · Lin-Zhi International, Inc.
DLJ · Calibrators, Drug Specific · 43d
Cleared Jun 13, 2002
PRECISET DAT PLUS
K021393 · Quantimetrix Corp.
DKB · Calibrators, Drug Mixture · 42d
Cleared Jun 11, 2002
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
K020869 · Worldwide Medical Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 85d
Cleared Jun 10, 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066 · Princeton BioMeditech Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 182d
Cleared Jun 10, 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
K014067 · Princeton BioMeditech Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 182d
Cleared Jun 10, 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · Princeton BioMeditech Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 182d
Cleared Jun 10, 2002
STARTOX DRUG OF ABUSE SCREENING TEST
K021006 · Starplex Scientific, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 74d
Cleared Jun 05, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
K013654 · Precision Systems, Inc.
JJF · Analyzer, Chemistry, Micro, For Clinical Use · 211d

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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