> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Fentanyl Detection Kit Gains Clearance
- URL: https://www.fdaweb.com/fentanyl-detection-kit-gains-clearance/
- Published: 2023-07-26T12:00:00.000Z
- Updated: 2026-09-14T18:46:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154955

FDA has cleared a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human urine. The Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for use with Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN. It provides a preliminary test result, according to the company, and a more specific alternative chemical method must be used to confirm the analytical result. Carolina Liquid is the authorized distributor for the test.

The device uses the “principle of competitive and fluorescence immunochromatography assay and uses fluorescence microspheres-labeled monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine,” the company says. It promises results in under six minutes.