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
Online retail giant Amazon.com Inc. (AMZN) is reportedly in talks to buy luxury online fashion retailer Net-a-Porter. The news of acquisition was first reported by Women's Wear Daily, which said the deal would be completed for about 2 billion euros, indicating the biggest acquisition yet by Amazon.... Tim Cook, the CEO of tech giant Apple Inc., in an interview said he intends to give away all his wealth to charity. Cook, in an interview to Fortune, said he plans to donate all his wealth to philanthropic projects after paying for his 10-year old nephew's college education. According to Fortune,... Is it a 'personal life crisis' that led the Germanwings' co-pilot Andreas Lubitz to deliberately lowering the plane carrying 149 people to French Alps mountain? Police is investigating to find evidences to prove this suggestion.
comments powered by Disqus
Follow RTT