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# FDA Clears Immunalysis Fentanyl Immunoassay
- URL: https://www.fdaweb.com/fda-clears-immunalysis-fentanyl-immunoassay/
- Published: 2017-07-31T12:00:00.000Z
- Updated: 2026-09-14T22:37:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139267

FDA has cleared an Immunalysis 510(k) for the Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in urine. The device is the first analyte utilizing Immunalysis’ proprietary Sefria technology. Previously, fentanyl immunoassay tests were only available for forensic testing, according to the company. With the clearance, fentanyl drug screening is now available for CLIA (Clinical Laboratory Improvement Amendments)-certified reference laboratories, hospitals, physician offices and other healthcare settings that perform moderate complexity testing. “The availability of an FDA-cleared fentanyl immunoassay enables more reference and hospital laboratories to conduct precise qualitative screening, which is a key strategy in stemming the alarming increase in misuse and abuse of fentanyl,” Immunalysis says.