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
801–825 of 3029
Cleared Mar 20, 2001
ESCREEN SYSTEM
K003352 · Escreen, Inc.
LAF · Gas Chromatography, Methamphetamine · 145d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 118d
Cleared Mar 08, 2001
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
K004034 · Branan Medical Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 70d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 77d
Cleared Feb 14, 2001
PROFILE II ER
K010138 · Medtox Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 28d
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 Feb 05, 2001
LIVESURE THC SCREEN TEST
K010001 · Pan Probe Biotech, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 34d
Cleared Jan 26, 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · OraSure Technologies, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 175d
Cleared Jan 22, 2001
ADVANTAGE THC/COCAINE TEST
K003708 · Advantage Diagnostics Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 52d
Cleared Jan 17, 2001
PROFILE-ER
K002331 · Medtox Diagnostics, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 169d
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
K003687 · Medtox Diagnostics, Inc.
DKE · Reagents, Test, Tetrahydrocannabinol · 22d
Cleared Dec 11, 2000
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
K000851 · Psychemedics Corp.
DJG · Enzyme Immunoassay, Opiates · 271d
Cleared Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · OraSure Technologies, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 160d
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 29, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010 · OraSure Technologies, Inc.
DJR · Enzyme Immunoassay, Methadone · 149d
Cleared Nov 29, 2000
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · Worldwide Medical Corp.
LAF · Gas Chromatography, Methamphetamine · 383d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
K002263 · Branan Medical Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
K002264 · Branan Medical Corporation
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
K002265 · Branan Medical Corporation
DJC · Thin Layer Chromatography, Methamphetamine · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
K002268 · Branan Medical Corporation
DJG · Enzyme Immunoassay, Opiates · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
K002342 · Branan Medical Corporation
JXM · Enzyme Immunoassay, Benzodiazepine · 118d
Cleared Nov 27, 2000
SYNCHRON CONTROL
K003488 · Beckman Coulter, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 14d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
K002266 · Branan Medical Corporation
DKZ · Enzyme Immunoassay, Amphetamine · 120d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
K002272 · Branan Medical Corp.
LCM · Enzyme Immunoassay, Phencyclidine · 119d

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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