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
451–475 of 2046
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K011672 · ACON Laboratories, Inc.
LAF · Gas Chromatography, Methamphetamine · 62d
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673 · ACON Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 62d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 88d
Cleared Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · ACON Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 110d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302 · Randox Laboratories, Ltd.
KXT · Enzyme Immunoassay, Digoxin · 63d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303 · Randox Laboratories, Ltd.
DLZ · Enzyme Immunoassay, Phenobarbital · 63d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co.
LEG · Enzyme Immunoassay, Valproic Acid · 11d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · Teco Diagnostics
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 151d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp.
DJG · Enzyme Immunoassay, Opiates · 65d
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
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · Syva Co.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 15d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · Phamatech
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 22d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · Phamatech
LAF · Gas Chromatography, Methamphetamine · 22d

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All categories 2046 DJG Enzyme Immunoassay, Opiates 122 DIF Drug Mixture Control Materials 104 DKZ Enzyme Immunoassay, Amphetamine 103 DLJ Calibrators, Drug Specific 84 LDJ Enzyme Immunoassay, Cannabinoids 78 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 72 DKB Calibrators, Drug Mixture 68 JXM Enzyme Immunoassay, Benzodiazepine 66 DIS Enzyme Immunoassay, Barbiturate 65 KXT Enzyme Immunoassay, Digoxin 50 LAS Drug Specific Control Materials 49 LCM Enzyme Immunoassay, Phencyclidine 48 DJR Enzyme Immunoassay, Methadone 45 KLS Enzyme Immunoassay, Theophylline 41 DIP Enzyme Immunoassay, Diphenylhydantoin 32