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
601–625 of 3029
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 07, 2003
COZART EIA OPIATES ORAL FLUID KIT
K024339 · Cozart Bioscience , Ltd.
DIG · Cholinesterase Test Paper · 101d
Cleared Apr 03, 2003
PRECISET DAT AMPHETAMINE
K030826 · Quantimetrix Corp.
DIJ · Lead, Delta Amino Levulinic Acid · 20d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · Microgenics Corp.
LAS · Drug Specific Control Materials · 33d
Cleared Feb 27, 2003
STARTOX DRUG OF ABUSE SCREENING TEST (4)
K022388 · Starplex Scientific, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 219d
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 31, 2003
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K023712 · Advantage Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 88d
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
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
K023101 · Amedica Biotech, Inc.
LAF · Gas Chromatography, Methamphetamine · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN AMPHETAMINE TEST
K023104 · Amedica Biotech, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
K023109 · Amedica Biotech, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 89d
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 16, 2002
QUICKTOX MULTIPLE DRUG DIPCARD
K023489 · Branan Medical Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 60d
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 22, 2002
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
K023252 · Icn Biomedicals, Inc.
DJR · Enzyme Immunoassay, Methadone · 53d
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 Nov 06, 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954 · Amedica Biotech, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 62d

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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