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
95d
Avg (2y)
1976
Since
2617 Toxicology devices
501–525 of 2617
Cleared Apr 28, 2004
HEMOSONIC 200HEMODYNAMIC MONITOR
K040802 · Arrow Intl., Inc.
DPN · Thin Layer Chromatography, Propoxyphene · 30d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
K033866 · Lin-Zhi International, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 117d
Cleared Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879 · Maine Standards Co.
DKB · Calibrators, Drug Mixture · 74d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
K033809 · Dade Behring, Inc.
KLR · Enzyme Immunoassay, Lidocaine · 74d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
K032903 · ACON Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 153d
Cleared Feb 17, 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
K033047 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 141d
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 60d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · Dade Behring, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 75d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · Roche Diagnostics Corp.
LBZ · Enzyme Immunoassay, Quinidine · 167d
Cleared Dec 19, 2003
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
K033094 · Lin-Zhi International, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 81d
Cleared Dec 12, 2003
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · ACON Laboratories, Inc.
LAF · Gas Chromatography, Methamphetamine · 59d
Cleared Dec 12, 2003
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366 · Bio-Rad
DIF · Drug Mixture Control Materials · 52d
Cleared Dec 12, 2003
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
K033404 · Bio-Rad
DIF · Drug Mixture Control Materials · 49d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · Roche Diagnostics Corp.
DLJ · Calibrators, Drug Specific · 56d
Cleared Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
K032811 · Microgenics Corp.
LEH · Radioimmunoassay, Vancomycin · 76d
Cleared Nov 10, 2003
PROFILE -ER
K033334 · Medtox Diagnostics, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 25d
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

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All categories 2617 DJG Enzyme Immunoassay, Opiates 167 DKZ Enzyme Immunoassay, Amphetamine 165 DIF Drug Mixture Control Materials 131 LDJ Enzyme Immunoassay, Cannabinoids 115 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 106 DLJ Calibrators, Drug Specific 97 DIS Enzyme Immunoassay, Barbiturate 87 JXM Enzyme Immunoassay, Benzodiazepine 79 DKB Calibrators, Drug Mixture 76 LCM Enzyme Immunoassay, Phencyclidine 67 LAS Drug Specific Control Materials 63 KXT Enzyme Immunoassay, Digoxin 56 DJR Enzyme Immunoassay, Methadone 52 KLS Enzyme Immunoassay, Theophylline 44 KLT Enzyme Immunoassay, Carbamazepine 40