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.
FDA 510(k) Cleared Toxicology Devices
This page lists all 86 medical devices in the Toxicology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Drug screening assays, therapeutic drug monitoring and toxicology test panels.
- 84 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 152 days.
- Records available from 2015 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 86 medical devices in the Toxicology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 84 were cleared as substantially equivalent to a predicate device. Average FDA review time: 152 days. Records from 2015 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to toxicology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific toxicology device? Search by device name, K-number or manufacturer.
Search all Toxicology 510(k) devices