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
751–775 of 3029
Cleared Jun 25, 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · Advantage Diagnostics Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 90d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp.
DJG · Enzyme Immunoassay, Opiates · 65d
Cleared Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · Syva Co., Dade Behring, Inc.
LAN · Enzyme Immunoassay, N-acetylprocainamide · 24d
Cleared Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · Syva Co., Dade Behring, Inc.
LBZ · Enzyme Immunoassay, Quinidine · 19d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · Medtox Diagnostics, Inc.
LFG · Radioimmunoassay, Tricyclic Antidepressant Drugs · 21d
Cleared Jun 08, 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · Pan Probe Biotech, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 14d
Cleared Jun 08, 2001
LIVESURE METHAMPHETAMINE SCREEN TESTS
K011610 · Pan Probe Biotech, Inc.
LAF · Gas Chromatography, Methamphetamine · 14d
Cleared Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057 · OraSure Technologies, Inc.
PJD · Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device · 61d
Cleared Jun 01, 2001
VERDICT -II METHAMPHETAMINE
K010226 · Medtox Diagnostics, Inc.
DJC · Thin Layer Chromatography, Methamphetamine · 128d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · Alfa Scientific Designs, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 183d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · Alfa Scientific Designs, Inc.
LAF · Gas Chromatography, Methamphetamine · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847 · Alfa Scientific Designs, Inc.
LAF · Gas Chromatography, Methamphetamine · 168d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · Alfa Scientific Designs, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 165d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · Alfa Scientific Designs, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 165d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014 · Alfa Scientific Designs, Inc.
DJR · Enzyme Immunoassay, Methadone · 147d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015 · Alfa Scientific Designs, Inc.
DJR · Enzyme Immunoassay, Methadone · 147d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
K010045 · Alfa Scientific Designs, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 144d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047 · Alfa Scientific Designs, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 144d
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
K010079 · Alfa Scientific Designs, Inc.
DOE · Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. · 139d
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
K010080 · Alfa Scientific Designs, Inc.
DOE · Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. · 139d
Cleared May 29, 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · Alfa Scientific Designs, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 183d
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · Microgenics Corp.
LAF · Gas Chromatography, Methamphetamine · 97d
Cleared May 17, 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · Sun Biomedical Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 119d
Cleared May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · Syva Co., Dade Behring, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 17d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · Syva Co.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 15d

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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