FDA 510(k) Toxicology Devices
About Toxicology Devices
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.
3026
Total
3016
Cleared
87d
Avg days
1976
Since
128 Toxicology devices
Cleared
Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
DJG
Enzyme Immunoassay, Opiates
59d
Cleared
Dec 09, 2019
CEDIA Benzodiazepine Assay
JXM
Enzyme Immunoassay, Benzodiazepine
241d
Cleared
Nov 21, 2019
LZI Cotinine II Enzyme Immunoassay
MKU
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
90d
Cleared
Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
QBK
Meprobamate Test System
269d
Cleared
Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
DJR
Enzyme Immunoassay, Methadone
29d
Cleared
Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
LCM
Enzyme Immunoassay, Phencyclidine
269d
Cleared
Dec 03, 2018
LZI Fentanyl Enzyme Immunoassay
DJG
Enzyme Immunoassay, Opiates
216d
Cleared
Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
NFT
Test, Amphetamine, Over The Counter
67d
Not Cleared
Nov 19, 2018
QMS Plazomicin Immunoassay
QDR
Plazomicin Test System, Immunoassay
147d
Cleared
Nov 06, 2018
Elecsys Tacrolimus
MLM
Enzyme Immunoassay, Tracrolimus
321d
Cleared
Oct 31, 2018
Immunalysis Ethyl Alcohol Enzyme Assay
DIC
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
140d
Cleared
Jul 06, 2018
DRI Cocaine Metabolite Assay
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
29d
Not Cleared
Apr 20, 2018
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
QBK
Meprobamate Test System
423d
Cleared
Feb 23, 2018
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
DKZ
Enzyme Immunoassay, Amphetamine
128d
Cleared
Feb 21, 2018
DRI Benzodiazepine Assay
JXM
Enzyme Immunoassay, Benzodiazepine
55d
Cleared
Feb 13, 2018
DRI Hydrocodone Assay
DJG
Enzyme Immunoassay, Opiates
134d
Cleared
Nov 22, 2017
CEDIA Heroin Metabolite (6-AM) Assay
DJG
Enzyme Immunoassay, Opiates
51d
Cleared
Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
267d
Cleared
Oct 18, 2017
Emit II Plus Oxycodone Assay
DJG
Enzyme Immunoassay, Opiates
23d
Cleared
Aug 15, 2017
Rapid Tox Cup II
LAF
Gas Chromatography, Methamphetamine
202d
Cleared
Aug 11, 2017
xTAG CYP2D6 Kit v3
NTI
Drug Metabolizing Enzyme Genotyping Systems
175d
Cleared
Aug 02, 2017
Healgen Multi-Drug Urine Test Cup
JXM
Enzyme Immunoassay, Benzodiazepine
216d
Cleared
Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
DJR
Enzyme Immunoassay, Methadone
136d
Cleared
Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
DJG
Enzyme Immunoassay, Opiates
411d
Cleared
Apr 06, 2017
CEDIA Buprenorphine II Assay
DJG
Enzyme Immunoassay, Opiates
150d
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