NEW YORK – Abbott has received 510(k) clearance from the US Food and Drug Administration for its cardiac function test intended to help diagnose heart failure.
The Alere NT-proBNP assay for the Alinity I immunoassay system quantitatively detects N-terminal pro B-type natriuretic peptide in human serum and plasma. Measures of NT-proBNP are used to help diagnose heart failure in patients with clinical suspicion of new onset or worsening heart failure, a spokesperson for Abbott said.
The chemiluminescent microparticle immunoassay rounds out Abbott's cardiac menu for the firm's Alinity CI platform, which integrates clinical chemistry and immunoassay testing into one system for hospital laboratories.