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
1151–1175 of 3029
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · Greiner America, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 40d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287 · Beckman Instruments, Inc.
DKB · Calibrators, Drug Mixture · 31d
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 210d
Cleared Apr 25, 1997
PARAMAX SALICYLATE REAGENT
K964715 · Dade Intl., Inc.
DKJ · Colorimetry, Salicylate · 151d
Cleared Apr 17, 1997
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc.
LAS · Drug Specific Control Materials · 15d
Cleared Apr 14, 1997
RAPID DRUG SCREEN
K964900 · American Bio Medica Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 138d
Cleared Apr 08, 1997
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 190d
Cleared Apr 08, 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · Drial Consultants, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 75d
Cleared Mar 10, 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp.
DJG · Enzyme Immunoassay, Opiates · 266d
Cleared Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · Syntron Bioresearch, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 169d
Cleared Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 189d
Cleared Feb 14, 1997
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K964765 · Chiron Diagnostics Corp.
KLT · Enzyme Immunoassay, Carbamazepine · 79d
Cleared Feb 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
K964009 · Beckman Instruments, Inc.
DNO · Hemagglutination Inhibition, Gentamicin · 127d
Cleared Feb 04, 1997
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
K964670 · Roche Diagnostic Systems, Inc.
LFW · Fluorescence Polarization Immunoassay, Tobramycin · 75d
Cleared Feb 04, 1997
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
K964771 · Dyna-Tek Industries
DIF · Drug Mixture Control Materials · 69d
Cleared Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
K965157 · Boehringer Mannheim Corp.
DIF · Drug Mixture Control Materials · 25d
Cleared Jan 13, 1997
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587 · Bayer Corp.
LEH · Radioimmunoassay, Vancomycin · 59d
Cleared Dec 18, 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · Diagnostic Reagents, Inc.
LBZ · Enzyme Immunoassay, Quinidine · 57d
Cleared Dec 13, 1996
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
K963062 · Beckman Instruments, Inc.
KXT · Enzyme Immunoassay, Digoxin · 128d
Cleared Dec 13, 1996
NICCHECK I
K963733 · Dynagen, Inc.
MRS · Test System, Nicotine, Cotinine, Metabolites · 88d
Cleared Dec 13, 1996
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068 · Bayer Corp.
KLT · Enzyme Immunoassay, Carbamazepine · 64d
Cleared Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · Roche Diagnostic Systems, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 42d
Cleared Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · Boehringer Mannheim Corp.
JXM · Enzyme Immunoassay, Benzodiazepine · 148d
Cleared Dec 10, 1996
VERDICT PCP
K963692 · Editek, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 85d
Cleared Dec 10, 1996
DIGOXIN ENZYME IMMUNOASSAY
K963835 · Diagnostic Reagents, Inc.
KXT · Enzyme Immunoassay, Digoxin · 77d

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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