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: