February 2025—Werfen announced FDA 510(k) clearance for the Aptiva antiphospholipid syndrome immunoglobulin G and immunoglobulin M reagents. These immunoassay reagents use Aptiva’s particle-based multianalyte technology for the semiquantitative determination of anticardiolipin and anti-beta 2 glycoprotein 1 IgG and IgM in human serum and aid in diagnosing primary and secondary APS, when used in conjunction with other laboratory and clinical findings.
Aptiva is a next-generation fully automated multianalyte system that delivers up to 960 results in an eight-hour shift for APS testing. This latest clearance expands the Aptiva portfolio to 18 FDA-cleared analytes.
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