Roche Submits TnT-hs Assay to FDA for Clearance on the Cobas Immunoassay and Elecsys Analyzers

Roche RHHBY announced today that it has filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a fully automated TnT-hs assay for use on Roche's full portfolio of laboratory analyzers.* Intended as an aid in the in the diagnosis of myocardial infarction, the electrochemiluminescence (ECL) immunoassay is used for the in vitro quantitative determination of TnT-hs in human serum and plasma.