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
2615 Toxicology devices
251–275 of 2615
Cleared Feb 04, 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · Lin-Zhi International, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 244d
Cleared Jan 24, 2014
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES
K133642 · Biophor Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 58d
Cleared Jan 17, 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation
DJG · Enzyme Immunoassay, Opiates · 268d
Cleared Jan 15, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
K131110 · Co-Innovation Biotech Co., Ltd.
DKZ · Enzyme Immunoassay, Amphetamine · 271d
Cleared Dec 16, 2013
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
K132688 · Biochemical Diagnostics, Inc.
DIF · Drug Mixture Control Materials · 110d
Cleared Nov 13, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K131128 · Omega Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 204d
Cleared Oct 18, 2013
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
K132096 · Biophor Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 102d
Cleared Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · Alfa Scientific Designs, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 124d
Cleared Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
K132630 · Guangzhou Wondfo Biotech Co., Ltd.
DJC · Thin Layer Chromatography, Methamphetamine · 36d
Cleared Sep 26, 2013
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
K130275 · Tianjin New Bay Bioresearch Co., Ltd.
DJG · Enzyme Immunoassay, Opiates · 234d
Cleared Sep 20, 2013
MULTICHEM WBT
K132174 · Techno-Path Manufacturing , Ltd.
DIF · Drug Mixture Control Materials · 67d
Cleared Sep 11, 2013
XTAG CYP2C19 KIT V3
K131565 · Luminex Molecular Diagnostics, Inc.
NTI · Drug Metabolizing Enzyme Genotyping Systems · 104d
Cleared Aug 29, 2013
ARCHITECT IVANCOMYCIN
K123947 · Biokit, S.A.
LEH · Radioimmunoassay, Vancomycin · 251d
Cleared Aug 12, 2013
SPARTAN RX CYP2C19 TEST SYSTEM
K123891 · Spartan Bioscience, Inc.
NTI · Drug Metabolizing Enzyme Genotyping Systems · 237d
Cleared Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
K132090 · Randox Laboratories, Ltd.
DLJ · Calibrators, Drug Specific · 27d
Not Cleared Aug 08, 2013
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
DEN130005 · Centers For Disease Control and Prevention
PDY · Organophosphate Test System · 72d
Cleared Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754 · Guangzhou Wondfo Biotech Co., Ltd.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 47d
Cleared Jul 19, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · Ucp Biosciences, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 30d
Cleared Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · Microgenics Corp.
MLM · Enzyme Immunoassay, Tracrolimus · 253d
Cleared Jun 25, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
K131181 · Omega Laboratories, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 61d
Cleared Jun 17, 2013
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
K122809 · Advin Biotech
DKZ · Enzyme Immunoassay, Amphetamine · 277d
Cleared Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
K123518 · Microgenics Corporation
KLT · Enzyme Immunoassay, Carbamazepine · 203d
Cleared May 31, 2013
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232 · Guangzhou Wondfo Biotech Co., Ltd.
DJR · Enzyme Immunoassay, Methadone · 30d
Cleared May 24, 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
K121065 · Polymed Therapeutics, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 413d
Cleared May 15, 2013
UCP HOME DRUG SCREENING TEST
K130463 · Ucp Biosciences, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 82d

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All categories 2615 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