Skip to main content
Premium Trial:

Request an Annual Quote

Roche Gets FDA Clearance for Hemoglobin Analyzer, Assay

NEW YORK (360Dx) – Roche announced today that it has received US Food and Drug Administration approval for its Cobas c 513 analyzer and Tina-quant HbA1c Gen. 3 assay.

HbA1c is a form of hemoglobin used as measure of average plasma glucose concentration in the management of diabetes.

The Cobas c 513 analyzer is a dedicated instrument for HbA1c analysis with a throughput of 400 patient results per hour — twice the throughput of the Cobas Integra 800 CTS instrument it replaces, according to Roche. It maintains the same footprint as its predecessor, and offers direct results reporting and closed tube sampling.

The assay, the company said, can be used to diagnose diabetes, identify people at risk of developing the disease, and for ongoing patient monitoring.

"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," Alan Wright, chief medical officer of Roche Diagnostics, said in a statement.