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FDA approves Roche’s cobas c 513 analyzer and HbA1c Gen. 3 assay

MDBR Staff Writer Published 05 January 2017

Roche has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cobas c 513 analyzer and Tina-quant HbA1c Gen. 3 assay to help in testing of people with diabetes.

The cobas c 513 analyzer, which will replace Cobas Integra 800 CTS, can increase throughput to 400 patient results per hour.

It also features direct results reporting, which can help to minimize the risk of result misinterpretation and avoid to carry out the time-consuming, manual result interpretation.

Featuring closed tube sampling, the analyzer will offer high on-board test capacity of up to 18,000 tests.

The cobas c 513 analyzer will run Tina-quant HbA1c Gen.3 assay, which is complied with current guidelines and recommendations for HbA1c testing and measures as defined by IFCC/NGSP reference methods.

The assay can deliver accurate monitoring of HbA1c levels without interference of most known HbA1c variants.

Roche Diagnostics chief medical officer Dr Alan Wright said: https://s.yimg.com/g/images/spaceball.gif"As diabetes continues to approach epidemic proportions in the U.S. with an estimated 1.4 million American adults being diagnosed annually, the demand on healthcare providers and healthcare systems to keep up with this challenging health issue continues to increase.

"With the FDA approval of the new cobas c 513 analyzer and proven HbA1c Gen. 3 assay, Roche is now positioned to help healthcare organizations address the increasing need for HbA1c testing with a dedicated solution that enables them to consistently deliver confident, efficient and high-quality results."


Image: Roche Diagnostics North American headquarters in Indianapolis. Photo: courtesy of PRNewsFoto/ Roche.