logo
Share SHARE
FONT-SIZE Plus   Neg

Roche Submits TnT-hs Assay For Clearance On Cobas Immunoassay, Elecsys Analyzers

Roche (RHHBY.PK) announced that it has filed a 510(k) submission to the U.S. Food and Drug Administration or 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, the company said.

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, the company said.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
A new Nike ad, "Unlimited Pursuit," highlights the hard work and dedication of female Olympians it takes to be the best. The latest installment in the Nike "Unlimited" - Just Do It campaign features some of world's greatest athletes from Rio 2016 Olympics. Gymnasts Simone Biles and Gabby Douglas, tennis player Serena Williams and many others are shown in the 40-second clip. Amazon.com on Wednesday announced the launch of Kindle Reading Fund, aiming to donate Kindle e-reader, Fire tablets, and Kindle eBooks globally to make books more easily available for digital reading. For this purpose, the company joining hands with local schools and libraries, hospitals, PTA as well as nonprofit organizations, mainly Worldreader. A federal judge has dismissed a lawsuit that accused Starbucks (SBUX) of cheating customers by "under-filling" its cold beverages. The lawsuit alleged that Starbucks is deceiving its customers by serving iced drinks with too much ice cubes and less coffee "than advertised." "If children have figured...
comments powered by Disqus
Follow RTT