The FDA announced marketing authorization of the Synovasure Lateral Flow Test Kit by CD Diagnostics Inc. to help detect periprosthetic joint infection in the synovial fluid of patients who are assessed for revision surgery. Data on the kit were reviewed through the de novo premarket review pathway.
“Prior to today’s authorization, there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release. “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. 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.”
According to the release, the Synovasure kit detects human alpha defensin proteins in the synovial fluid of patients with total joint replacement in about 10 minutes. The kit is intended to act as an aid to determine if there is an infection in the synovial fluid; however, it does not detect a specific infection.
With this authorization, the FDA will develop special controls to determine the requirements that will demonstrate the safety and efficacy of the test kit to detect non-microbial analytes.