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
651–675 of 2618
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
Cleared May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · Syva Co., Dade Behring, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 16d
Cleared May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
K011161 · Syva Co., Dade Behring, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 29d
Cleared May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289 · Syva Co., Dade Behring, Inc.
DJG · Enzyme Immunoassay, Opiates · 18d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · Syva Co., Dade Behring, Inc.
KXS · Radioimmunoassay, Methaqualone · 24d
Cleared May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · Syva Co., Dade Behring, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 16d
Cleared Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · Syva Co., Dade Behring, Inc.
DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · 27d
Cleared Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · Syva Co., Dade Behring, Inc.
DJR · Enzyme Immunoassay, Methadone · 27d

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All categories 2618 DJG Enzyme Immunoassay, Opiates 167 DKZ Enzyme Immunoassay, Amphetamine 165 DIF Drug Mixture Control Materials 131 LDJ Enzyme Immunoassay, Cannabinoids 115 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 106 DLJ Calibrators, Drug Specific 97 DIS Enzyme Immunoassay, Barbiturate 87 JXM Enzyme Immunoassay, Benzodiazepine 79 DKB Calibrators, Drug Mixture 76 LCM Enzyme Immunoassay, Phencyclidine 67 LAS Drug Specific Control Materials 63 KXT Enzyme Immunoassay, Digoxin 56 DJR Enzyme Immunoassay, Methadone 52 KLS Enzyme Immunoassay, Theophylline 44 KLT Enzyme Immunoassay, Carbamazepine 40