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# Roche Seeks Clearance of New Cobas for Diabetes
- URL: https://www.fdaweb.com/roche-seeks-clearance-of-new-cobas-for-diabetes/
- Published: 2016-03-02T12:00:00.000Z
- Updated: 2026-09-15T02:40:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134946

> Roche has submitted a 510(k) for the cobas c 513 analyzer as a dedicated, high-throughput HbA1c testing solution for people with diabetes. The submission is intended to address the growing prevalence and incidence of diabetes, with projections of 39 million people in the U.S. affected by the disease by the end of the decade, the company says. The device is designed to increase laboratory efficiency by doubling the already market-leading throughput of the cobas Integra 800 CTS from 200 to 400 patient results per hour.  
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> The c 513 analyzer features direct results reporting to minimize result misinterpretation and eliminate the need to perform time-consuming, manual result interpretation, according to the company. It also features “closed tube sampling, which will reduce hands-on time, prevent sample contamination and ensure operator safety for laboratory personnel,” the company says.