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
351–375 of 3029
Cleared Jul 24, 2009
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
K091454 · Medtox Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 67d
Cleared Jul 17, 2009
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
K091617 · Thermo Fisher Scientific
DLJ · Calibrators, Drug Specific · 44d
Cleared Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · Siemens Healthcare Diagnostics
DKB · Calibrators, Drug Mixture · 61d
Cleared May 29, 2009
QMS LIDOCAINE
K090282 · Thermo Fisher Scientific, Inc.
KLR · Enzyme Immunoassay, Lidocaine · 113d
Cleared May 01, 2009
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
K081938 · Genzyme Diagnostics P.E.I., Inc.
LDP · Colorimetry, Acetaminophen · 297d
Cleared Apr 16, 2009
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
K083799 · ARK Diagnostics, Inc.
NWM · Immunoassay, Anti-seizure Drug · 115d
Cleared Apr 01, 2009
ALCO TUBE PLUS
K082080 · Alcotest Quebec
DJZ · Devices, Breath Trapping, Alcohol · 252d
Cleared Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
K083487 · Siemens Healthcare Diagnostics
NRP · Sirolimus Test System · 125d
Cleared Mar 24, 2009
BACTRACK SELECT BREATHALYZER, MODEL S80
K090067 · Khn Solutions, LLC
DJZ · Devices, Breath Trapping, Alcohol · 74d
Cleared Mar 19, 2009
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
K083801 · Khn Solutions, LLC
DJZ · Devices, Breath Trapping, Alcohol · 87d
Cleared Feb 11, 2009
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
K080436 · Quantrx Biomedical Corporation
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 358d
Cleared Feb 06, 2009
EQ-PRC LC WARFARIN GENOTYPING KIT
K073071 · Trimgen Corporation
ODW · Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System · 464d
Cleared Jan 14, 2009
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · Thermo Fisher Scientific
DJR · Enzyme Immunoassay, Methadone · 243d
Cleared Jan 08, 2009
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
K080431 · Quantrx Biomedical Corporation
LCM · Enzyme Immunoassay, Phencyclidine · 324d
Cleared Dec 31, 2008
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
K080455 · Quantrx Biomedical Corporation
LAF · Gas Chromatography, Methamphetamine · 315d
Cleared Dec 22, 2008
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
K081008 · Lin-Zhi International, Inc.
DJG · Enzyme Immunoassay, Opiates · 256d
Cleared Dec 22, 2008
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
K082953 · Biokit, S.A.
KXT · Enzyme Immunoassay, Digoxin · 80d
Cleared Dec 19, 2008
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
K081083 · Thermo Fisher Scientific
OAV · Mycophenolic Acid Test System · 247d
Cleared Dec 19, 2008
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
K081855 · Canada, Inc.
DJZ · Devices, Breath Trapping, Alcohol · 172d
Cleared Dec 19, 2008
KEY RING ALCOHOL BREATHALYZER
K082086 · The Ashley Collection, Inc.
DJZ · Devices, Breath Trapping, Alcohol · 149d
Cleared Dec 19, 2008
AMEDICA DRUG SCREEN TEST CUP
K082898 · Amedica Biotech, Inc.
NGL · Test, Opiates, Over The Counter · 80d
Cleared Dec 05, 2008
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
K082001 · Diazyme Laboratories
JII · Atomic Absorption, Lithium · 144d
Cleared Nov 25, 2008
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
K080467 · Applied Dna Technologies, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 278d
Cleared Nov 21, 2008
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
K082508 · Branan Medical Corporation
DJG · Enzyme Immunoassay, Opiates · 84d
Cleared Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
K081857 · Siemens Healthcare Diagnostics, Inc.
NRP · Sirolimus Test System · 121d

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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