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.