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
Feb 13, 2015
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
DJG
Enzyme Immunoassay, Opiates
280d
Cleared
Feb 12, 2015
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
DJG
Enzyme Immunoassay, Opiates
224d
Cleared
Feb 06, 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
DKZ
Enzyme Immunoassay, Amphetamine
58d
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