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# Synovasure Lateral Flow Test Kit Cleared
- URL: https://www.fdaweb.com/synovasure-lateral-flow-test-kit-cleared/
- Published: 2019-05-24T12:00:00.000Z
- Updated: 2026-09-15T01:28:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144189

FDA has cleared a CD Diagnostics *de novo* marketing request for the Synovasure Lateral Flow Test Kit to serve as an aid for detecting periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant. “With this test, health care professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-diagnostic-test-aid-detecting-prosthetic-joint-infections?ref=fdaweb.com) says. “Whereas before surgeons may have opted for surgery when the presence of an infection was unclear, with this test, they have more information and could potentially reduce patient risk by avoiding unnecessary revision operations for replacement joints.”

The device is intended to detect proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in about 10 minutes. According to FDA, alpha defensins are antimicrobial proteins released by activated neutrophils (white blood cells) in response to an infection.