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
Cleared
May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
JXM
Enzyme Immunoassay, Benzodiazepine
16d
Cleared
May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
LCM
Enzyme Immunoassay, Phencyclidine
29d
Cleared
May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
DJG
Enzyme Immunoassay, Opiates
18d
Cleared
May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
KXS
Radioimmunoassay, Methaqualone
24d
Cleared
May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
16d
Cleared
Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
DIC
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
27d
Cleared
Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
DJR
Enzyme Immunoassay, Methadone
27d
Cleared
Apr 20, 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
DKZ
Enzyme Immunoassay, Amphetamine
133d
Cleared
Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
DIS
Enzyme Immunoassay, Barbiturate
23d
Cleared
Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
LCD
Enzyme Immunoassay, Gentamicin
18d
Cleared
Apr 17, 2001
LIVESURE COCAINE SCREEN TEST
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
15d
Cleared
Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
KLT
Enzyme Immunoassay, Carbamazepine
25d
Cleared
Apr 13, 2001
VERDICT -II BAR
DIS
Enzyme Immunoassay, Barbiturate
14d
Cleared
Apr 13, 2001
LIVESURE MORPHINE SCREEN TEST
DOE
Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
9d
Cleared
Apr 11, 2001
AT WORK DRUG TEST, MODEL 9177T AWT
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
22d
Cleared
Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
LAF
Gas Chromatography, Methamphetamine
22d
Cleared
Apr 05, 2001
VERDICT -II BAR/BZO
DIS
Enzyme Immunoassay, Barbiturate
38d
Cleared
Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
DKZ
Enzyme Immunoassay, Amphetamine
38d
Cleared
Apr 05, 2001
AT HOME DRUG TEST, MODEL 9068 T
MVO
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
31d
Cleared
Apr 05, 2001
AT HOME DRUG TEST, MODEL 9078 T
MVO
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
31d
Cleared
Apr 05, 2001
AT HOME DRUG TESTT, MODEL 9150 T
MVO
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
31d
Cleared
Mar 30, 2001
AT HOME DRUG TEST, MODEL 9063 T
DKZ
Enzyme Immunoassay, Amphetamine
25d
Cleared
Mar 30, 2001
AT HOME DRUG TEST, MODEL 9083 T
MVO
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
25d
Cleared
Mar 30, 2001
AT HOME DRUG TEST, MODEL 9073 T
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
25d
Cleared
Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
LCM
Enzyme Immunoassay, Phencyclidine
25d
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