Roche announced that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and HbA1c Gen. 3 assay has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The cobas c 513 analyzer further increases laboratory efficiency by doubling the throughput to 400 patient results per hour with the same footprint as the COBAS INTEGRA® 800 CTS, which it replaces. Additionally, the cobas c 513 analyzer features direct results reporting, thereby minimizing the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. The analyzer also provides a high on-board test capacity of up to 18,000 tests and features closed tube sampling for greater lab efficiencies and maximum operator safety. The cobas c 513 analyzer runs the established Roche Tina-quant® HbA1c Gen.3 assay, which is also used across the Roche laboratory HbA1c portfolio, to ensure confidence, efficiency and high-quality results. It complies with current guidelines and recommendations for HbA1c testing and measures A1c as defined by IFCC/NGSP reference methods. With no interference by most known HbA1c variants, the Roche Tina-quant HbA1c Gen. 3 assay delivers accurate monitoring of HbA1c levels and results that clinicians and patients can have confidence in.