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
376–400 of 2046
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · Microgenics Corp.
LAS · Drug Specific Control Materials · 33d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065 · Wako Chemicals USA, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 35d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp.
DLJ · Calibrators, Drug Specific · 90d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946 · ACON Laboratories, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 70d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
K023795 · Lin-Zhi International, Inc.
JXN · Enzyme Immunoassay, Propoxyphene · 69d
Cleared Dec 16, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K023316 · Lin-Zhi International, Inc.
DLJ · Calibrators, Drug Specific · 74d
Cleared Dec 12, 2002
METHADONE ENZYME IMMUNOASSAY
K023317 · Lin-Zhi International, Inc.
DJR · Enzyme Immunoassay, Methadone · 70d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · Ortho-Clinical Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 19d
Cleared Dec 09, 2002
INSTANT-VIEW TCA URINE TEST
K022693 · Alfa Scientific Designs, Inc.
MLK · Thin Layer Chromatography, Tricyclic Antidepressant Drugs · 118d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · Roche Diagnostics Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 66d
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · Roche Diagnostics Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 54d
Cleared Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501 · Alfa Scientific Designs, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 107d
Cleared Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · Beckman Coulter, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 55d
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 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 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 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 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · Lin-Zhi International, Inc.
DJG · Enzyme Immunoassay, Opiates · 120d

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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