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
476–500 of 2046
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9068 T
K010653 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 31d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9078 T
K010654 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 31d
Cleared Apr 05, 2001
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 31d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · Phamatech
DKZ · Enzyme Immunoassay, Amphetamine · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9083 T
K010646 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · Phamatech
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
K010651 · Phamatech
LCM · Enzyme Immunoassay, Phencyclidine · 25d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 118d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 77d
Cleared Feb 12, 2001
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 61d
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 Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · Diagnostic Chemicals , Ltd.
KHS · Enzymatic, Carbon-dioxide · 55d
Cleared Aug 14, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403 · Alfa Scientific Designs, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 230d
Cleared Aug 14, 2000
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
K994406 · Alfa Scientific Designs, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 230d
Cleared Aug 07, 2000
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · Alfa Scientific Designs, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 223d
Cleared Aug 04, 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · Alfa Scientific Designs, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 220d
Cleared Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
K994400 · Alfa Scientific Designs, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 220d
Cleared Jul 27, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · Alfa Scientific Designs, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 212d
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 Jul 10, 2000
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
K994409 · Alfa Scientific Designs, Inc.
DPK · Liquid Chromatography, Morphine · 195d
Cleared Jul 05, 2000
INSTANT-VIEW MORPHINE URINE CASSETTE TEST
K994404 · Alfa Scientific Designs, Inc.
DPK · Liquid Chromatography, Morphine · 190d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 55d

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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