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
651–675 of 3029
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · Lin-Zhi International, Inc.
DJG · Enzyme Immunoassay, Opiates · 120d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
K020395 · Lin-Zhi International, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 118d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · Biosite Incorporated
DKZ · Enzyme Immunoassay, Amphetamine · 159d
Cleared May 23, 2002
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
K014192 · Princeton BioMeditech Corp.
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 153d
Cleared May 23, 2002
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · Princeton BioMeditech Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 153d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · ACON Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 68d
Cleared May 10, 2002
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · Lin-Zhi International, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 106d
Cleared May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
K020692 · Dade Behring, Inc.
LEH · Radioimmunoassay, Vancomycin · 67d
Cleared May 10, 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
K020763 · Lin-Zhi International, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 64d
Cleared May 08, 2002
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD
K020313 · Acon Laboratories Co.
DKZ · Enzyme Immunoassay, Amphetamine · 98d
Cleared May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · Dade Behring, Inc.
DLJ · Calibrators, Drug Specific · 54d
Cleared May 06, 2002
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
K020716 · Rapid Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 62d
Cleared May 03, 2002
PSYCHEMEDICS RIA CANNABINOID ASSAY
K011426 · Psychemedics Corp.
LAT · Radioimmunoassay, Cannabinoid(s) · 360d
Cleared May 02, 2002
VERDICT-II PROPOXYPHENE
K020787 · Medtox Diagnostics, Inc.
JXN · Enzyme Immunoassay, Propoxyphene · 52d
Cleared Apr 25, 2002
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089 · Sun Biomedical Laboratories, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 135d
Cleared Apr 17, 2002
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
K013882 · OraSure Technologies, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 145d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740 · Roche Diagnostics Corp.
KLS · Enzyme Immunoassay, Theophylline · 41d
Cleared Apr 03, 2002
UPLINK TEST SYSTEM
K020371 · OraSure Technologies, Inc.
DJG · Enzyme Immunoassay, Opiates · 58d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · Lin-Zhi International, Inc.
DLJ · Calibrators, Drug Specific · 27d
Cleared Mar 28, 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · Dade Behring, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 45d
Cleared Mar 20, 2002
BARBITURATES
K012996 · Abbott Laboratories
DIS · Enzyme Immunoassay, Barbiturate · 195d
Cleared Mar 20, 2002
METHADONE
K013001 · Abbott Laboratories
DJR · Enzyme Immunoassay, Methadone · 195d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · Abbott Laboratories
JXN · Enzyme Immunoassay, Propoxyphene · 184d
Cleared Mar 20, 2002
RAPIDONE-OXY TEST
K014101 · American Bio Medica Corp.
DJG · Enzyme Immunoassay, Opiates · 97d
Cleared Mar 20, 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136 · Sun Biomedical Laboratories, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 64d

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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