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

95d

Avg (2y)

1976

Since

2618 Toxicology devices

676–700 of 2618

Cleared Apr 20, 2001

EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229

K010934 · Syva Co., Dade Behring, Inc.

DIS · Enzyme Immunoassay, Barbiturate · 23d

Cleared Apr 20, 2001

EMIT 2000 GENTAMICIN PLUS ASSAY

K010984 · Syva Co., Dade Behring, Inc.

LCD · Enzyme Immunoassay, Gentamicin · 18d

Cleared Apr 13, 2001

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

K010814 · Syva Co., Dade Behring, Inc.

KLT · Enzyme Immunoassay, Carbamazepine · 25d

Cleared Apr 13, 2001

VERDICT -II BAR

K010959 · Medtox Diagnostics, Inc.

DIS · Enzyme Immunoassay, Barbiturate · 14d

Cleared Apr 11, 2001

AT WORK DRUG TEST, MODEL 9177T AWT

K010833 · Phamatech

DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 22d

Cleared Apr 11, 2001

AT WORK DRUG TEST, MODEL 9147T AWT

K010836 · Phamatech

LAF · Gas Chromatography, Methamphetamine · 22d

Cleared Apr 05, 2001

VERDICT -II BAR/BZO

K010561 · Medtox Diagnostics, Inc.

DIS · Enzyme Immunoassay, Barbiturate · 38d

Cleared Apr 05, 2001

VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO

K010564 · Medtox Diagnostics, Inc.

DKZ · Enzyme Immunoassay, Amphetamine · 38d

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 14, 2001

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 Jan 26, 2001

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

K002375 · OraSure Technologies, Inc.

LDJ · Enzyme Immunoassay, Cannabinoids · 175d

Cleared Jan 17, 2001

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 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

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