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
551–575 of 3029
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 60d
Cleared Feb 10, 2004
LABONE MICRO-PLATE COTININE EIA
K033601 · Labone, Inc.
DLJ · Calibrators, Drug Specific · 88d
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 20, 2004
ONTRAK TESTCUP II AND ONSITE CUPKIT
K033902 · Varian, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 34d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · Roche Diagnostics Corp.
LBZ · Enzyme Immunoassay, Quinidine · 167d
Cleared Jan 06, 2004
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
K033659 · Varian, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 46d
Cleared Dec 19, 2003
INSTAREAD LITHIUM SYSTEM
K031579 · Akers Laboratories, Inc.
JIH · Flame Photometry, Lithium · 213d
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 17, 2003
AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
K031497 · Amedica Biotech, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 157d
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 29, 2003
AML HAIRCHECK-DT (COCAINE)
K023626 · Quest Diagnostics, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 335d
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 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