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
526–550 of 3029
Cleared Jul 13, 2004
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
K041221 · Accu-Stat Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 64d
Cleared Jun 23, 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp.
DJG · Enzyme Immunoassay, Opiates · 135d
Cleared Jun 14, 2004
QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
K040257 · Quest Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 131d
Cleared Jun 03, 2004
COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
K033743 · Cozart Bioscience , Ltd.
DKZ · Enzyme Immunoassay, Amphetamine · 188d
Cleared May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · Microgenics Corp.
DIF · Drug Mixture Control Materials · 64d
Cleared May 27, 2004
DRI OXYCODONE ASSAY
K040411 · Microgenics Corp.
LAS · Drug Specific Control Materials · 99d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 156d
Cleared May 19, 2004
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
K040445 · ACON Laboratories, Inc.
JXN · Enzyme Immunoassay, Propoxyphene · 89d
Cleared May 17, 2004
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
K033566 · Rapid Diagnostics, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 187d
Cleared May 17, 2004
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
K040464 · Amedica Biotech, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 84d
Cleared May 12, 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · Randox Laboratories, Ltd.
DKZ · Enzyme Immunoassay, Amphetamine · 90d
Cleared May 10, 2004
RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd.
DJR · Enzyme Immunoassay, Methadone · 67d
Cleared May 05, 2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629 · Accu-Stat Diagnostics, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 56d
Cleared May 03, 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 88d
Cleared Apr 28, 2004
HEMOSONIC 200HEMODYNAMIC MONITOR
K040802 · Arrow Intl., Inc.
DPN · Thin Layer Chromatography, Propoxyphene · 30d
Cleared Apr 19, 2004
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
K040327 · Accu-Stat Diagnostics, Inc.
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 69d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
K033866 · Lin-Zhi International, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 117d
Cleared Apr 02, 2004
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
K040352 · Bioresource Technology, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 50d
Cleared Mar 25, 2004
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22
K040203 · Branan Medical Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 56d
Cleared Mar 08, 2004
AMEDITECH IMMU TEST DRUG SCREEN PANEL
K040092 · Ameditech, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 52d
Cleared Mar 05, 2004
LABONE COCAINE METABOLITE MICRO-PLATE EIA
K040198 · Labone, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 36d
Cleared Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879 · Maine Standards Co.
DKB · Calibrators, Drug Mixture · 74d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
K033809 · Dade Behring, Inc.
KLR · Enzyme Immunoassay, Lidocaine · 74d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
K032903 · ACON Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 153d
Cleared Feb 17, 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
K033047 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 141d

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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