Roche has submitted TnT-hs assay's 510(k) application to the US Food and Drug Administration (FDA) for use on its cobas immunoassay and Elecsys analyzers.
The TnT-hs is an electrochemiluminescence immunoassay designed for in-vitro quantitative determination of TnT-hs in human serum and plasma as well as used in the diagnosis of myocardial infarction.
The advantage of the TnT-hs assay includes improved analytical imprecision at concentrations below the 99th percentile of normal.
The company's portfolio of other cardiac tests include Troponin T, Troponin I , NT-proBNP, CK-MB, Myoglobin and D-Dimer.
The FDA has a 90-day period after the 510(k) submission for substantive review of the application.
Source:
http://invitrodiagnostics.medicaldevices-business-review.com/news/roche-submits-tnt-hs-assay-510k-application-to-fda-080612
