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

551–575 of 2046

Cleared Dec 30, 1999

AT HOME DRUG TEST, MODEL 9083

K994234 · Phamatech

DJG · Enzyme Immunoassay, Opiates · 14d

Cleared Dec 30, 1999

AT HOME DRUG TEST, MODEL 9133

K994236 · Phamatech

LCM · Enzyme Immunoassay, Phencyclidine · 14d

Cleared Dec 30, 1999

AT HOME DRUG TEST, MODEL 9063

K994237 · Phamatech

DKZ · Enzyme Immunoassay, Amphetamine · 14d

Cleared Dec 21, 1999

BIO-RAD HOMOCYSTEINE BY HPLC

K993107 · Bio-Rad

LPS · Urinary Homocystine (nonquantitative) Test System · 95d

Cleared Dec 21, 1999

EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5

K993755 · Syva Co.

DKB · Calibrators, Drug Mixture · 46d

Cleared Dec 16, 1999

AT WORK DRUG TEST, MODEL 9145-25C

K994093 · Phamatech

LCL · Radioimmunoassay, Phencyclidine · 13d

Cleared Nov 26, 1999

SYNCHRON SYSTEMS DRUG CALIBRATOR 2

K993473 · Beckman Coulter, Inc.

DLJ · Calibrators, Drug Specific · 43d

Cleared Nov 23, 1999

ROCHE COBAS INTEGRA OPIATES 300/2000

K992890 · Roche Diagnostics Corp.

DJG · Enzyme Immunoassay, Opiates · 88d

Cleared Nov 09, 1999

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

K993022 · Beckman Coulter, Inc.

DLJ · Calibrators, Drug Specific · 61d

Cleared Oct 20, 1999

QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178

K993165 · Phamatech

DJG · Enzyme Immunoassay, Opiates · 28d

Cleared Oct 06, 1999

QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C

K992685 · Phamatech

MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 57d

Cleared Aug 30, 1999

CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3

K992430 · Medical Analysis Systems, Inc.

JJT · Enzyme Controls (assayed And Unassayed) · 40d

Cleared Aug 19, 1999

OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2

K992086 · Olympus America, Inc.

JIX · Calibrator, Multi-analyte Mixture · 59d

Cleared Aug 10, 1999

ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3

K992422 · Princeton BioMeditech Corp.

DJG · Enzyme Immunoassay, Opiates · 20d

Cleared Jul 22, 1999

COBAS INTEGRA AMIKACIN MAB

K991597 · Roche Diagnostics Corp.

LGJ · Fluorescence Polarization Immunoassay, Amibacin · 73d

Cleared Jul 22, 1999

COBAS INTEGRA ACETAMINOPHEN

K991598 · Roche Diagnostics Corp.

LDP · Colorimetry, Acetaminophen · 73d

Cleared Jul 13, 1999

AT HOME DRUG TEST, MODEL 9175

K992217 · Phamatech

MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 12d

Cleared Jul 06, 1999

STATUS STIK, ACCUSIGN STIK

K992068 · Princeton BioMeditech Corp.

DKE · Reagents, Test, Tetrahydrocannabinol · 18d

Cleared Jun 22, 1999

ROCHE COBAS INTEGRA SERUM BARBITURATES

K991440 · Roche Diagnostics Corp.

DIS · Enzyme Immunoassay, Barbiturate · 57d

Cleared Jun 22, 1999

ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)

K991443 · Roche Diagnostics Corp.

JXM · Enzyme Immunoassay, Benzodiazepine · 57d

Cleared Jun 18, 1999

STATUS CUP ACCUSIGN CUP

K991751 · Princeton BioMeditech Corp.

DKE · Reagents, Test, Tetrahydrocannabinol · 25d

Cleared Jun 11, 1999

AT HOME DRUG TEST, MODEL 9171

K991824 · Phamatech

MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 15d

Cleared Jun 01, 1999

AT HOME COCAINE & THC SCREENING TEST, MODEL 9170

K991641 · Phamatech

MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 20d

Cleared May 03, 1999

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES

K983698 · Roche Diagnostic Systems, Inc.

DIS · Enzyme Immunoassay, Barbiturate · 194d

Cleared Apr 16, 1999

LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405

K990928 · Bio-Rad

DIE · Heavy Metals Control Materials · 28d

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