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
326–350 of 2046
Cleared Sep 09, 2004
ACON TRI-FECT DRUG SCREEN TEST DEVICE
K041743 · ACON Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 73d
Cleared Aug 30, 2004
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685 · ACON Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 69d
Cleared Aug 17, 2004
DC-ACETA/SAL CONTROLS
K041666 · Diagnostic Chemicals , Ltd.
DIF · Drug Mixture Control Materials · 60d
Cleared Jun 23, 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp.
DJG · Enzyme Immunoassay, Opiates · 135d
Cleared May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · Microgenics Corp.
DIF · Drug Mixture Control Materials · 64d
Cleared May 27, 2004
DRI OXYCODONE ASSAY
K040411 · Microgenics Corp.
LAS · Drug Specific Control Materials · 99d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 156d
Cleared May 19, 2004
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
K040445 · ACON Laboratories, Inc.
JXN · Enzyme Immunoassay, Propoxyphene · 89d
Cleared May 12, 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd.
DKZ · Enzyme Immunoassay, Amphetamine · 90d
Cleared May 10, 2004
RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd.
DJR · Enzyme Immunoassay, Methadone · 67d
Cleared May 03, 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 88d
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 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

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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