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.

3027
Total
3017
Cleared
90d
Avg (2y)
1976
Since
1235 Toxicology devices
276–300 of 1235
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · Roche Diagnostics Corp.
DJG · Enzyme Immunoassay, Opiates · 63d
Cleared Dec 14, 2001
ETHANOL
K013538 · Abbott Laboratories
DML · Nad-nadh, Specific Reagent For Alcohol Enzyme Method · 51d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · Beckman Coulter, Inc.
LEH · Radioimmunoassay, Vancomycin · 89d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 101d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp.
KXT · Enzyme Immunoassay, Digoxin · 61d
Cleared Aug 20, 2001
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · Diagnostic Products Corp.
KLB · Radioimmunoassay, Tobramycin · 28d
Cleared Aug 13, 2001
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
K011878 · Syva Co.
DKJ · Colorimetry, Salicylate · 59d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co.
LEG · Enzyme Immunoassay, Valproic Acid · 11d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · Syva Co.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 15d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 77d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · Diagnostic Products Corp.
LPS · Urinary Homocystine (nonquantitative) Test System · 76d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · Dade Behring, Inc.
DJG · Enzyme Immunoassay, Opiates · 53d
Cleared Nov 27, 2000
SYNCHRON CONTROL
K003488 · Beckman Coulter, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 14d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 68d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · Roche Diagnostics Corp.
DJC · Thin Layer Chromatography, Methamphetamine · 73d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 55d
Cleared May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606 · Beckman Coulter, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 72d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · Roche Diagnostics Corp.
LAF · Gas Chromatography, Methamphetamine · 104d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · Dade Behring, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 66d
Cleared Apr 14, 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · Dade Behring, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 63d
Cleared Apr 14, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · Dade Behring, Inc.
DJG · Enzyme Immunoassay, Opiates · 63d
Cleared Apr 14, 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · Dade Behring, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 63d
Cleared Apr 14, 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · Beckman Coulter, Inc.
LDP · Colorimetry, Acetaminophen · 59d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · Roche Diagnostics Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 126d
Cleared Apr 10, 2000
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410 · Beckman Coulter, Inc.
DMT · Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet · 62d

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All categories 1235 DJG Enzyme Immunoassay, Opiates 78 DKZ Enzyme Immunoassay, Amphetamine 64 DIF Drug Mixture Control Materials 58 DLJ Calibrators, Drug Specific 57 LDJ Enzyme Immunoassay, Cannabinoids 54 JXM Enzyme Immunoassay, Benzodiazepine 47 DKB Calibrators, Drug Mixture 47 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 42 LAS Drug Specific Control Materials 39 DIS Enzyme Immunoassay, Barbiturate 37 LCM Enzyme Immunoassay, Phencyclidine 33 NFT Test, Amphetamine, Over The Counter 29 KXT Enzyme Immunoassay, Digoxin 29 DJR Enzyme Immunoassay, Methadone 25 KLS Enzyme Immunoassay, Theophylline 24