Skip to main content
Premium Trial:

Request an Annual Quote

Werfen Receives FDA 510(k) Clearance for Antiphospholipid Syndrome Test Reagents

NEW YORK — Werfen said Monday that it has received US Food and Drug Administration 510(k) clearance for its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents.

The reagents are meant for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM levels in human serum to aid the diagnosis of primary and secondary APS.

The clearance of the reagents expands the portfolio of assays available on the Aptiva platform to 18 FDA-cleared analytes including reagents for celiac disease and connective tissue diseases. According to San Diego-based Werfen, the Aptiva platform can deliver up to 960 APS test results in eight hours.

"Antiphospholipid syndrome presents significant diagnostic challenges due to its complex symptomatology, often resembling other conditions," Michael Mahler, senior VP of research and development at Werfen, said in a statement. "The FDA clearance of the Aptiva APS IgG and APS IgM reagents marks a crucial step forward in our mission to enhance diagnostic accuracy for autoimmune diseases."