Roche files TnT-hs assay 510(k) submission with FDA for use on laboratory analyzers

Roche (SIX: RO, ROG; OTCQX: 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.

Roche Diagnostics offers a full selection of cardiac tests in its portfolio:  Troponin T (TnT), Troponin I (TnI), NT-proBNP, CK-MB, Myoglobin and D-Dimer.  The combination of  a full cardiac menu with the lowest time of analysis on the market (STAT assay of only 9 minutes), the broadest integrated menu and ECL technology allows the Roche total solution to inspire confidence in the laboratory environment.

The assay is designed for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments. The FDA has a 90-day period after the 510(k) submission for substantive review of the application.

Source:

Roche Diagnostics

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