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.