Roche submits510(k) for HbA1c testing solution for diabetes
March 2, 2016 – INDIANAPOLIS. Roche announced that it has submitted the cobas c 513 analyzer as a 510(k) to the U.S. Food and Drug Administration (FDA) as a dedicated, high-throughput HbA1c testing solution for people with diabetes.
“As the prevalence and incidence of diabetes continues to grow, it’s estimated that by the end of this decade 15 percent of American adults—or roughly 39 million people will be affected. This staggering number is not only a major cause for concern for healthcare providers, but for healthcare organizations as well,” said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. “With the submission of the cobas c 513 analyzer to the FDA for 510(k) clearance, Roche is dedicated to helping address the need to quickly identify, diagnose and monitor people with diabetes.”
Upon receiving FDA clearance for the cobas c 513 analyzer, Roche plans to replace its existing analyzer, the COBAS INTEGRA® 800 CTS, which has been a successful and well-established solution. The cobas c 513 analyzer will further increase laboratory efficiency by doubling the already market-leading throughput of the COBAS INTEGRA® 800 CTS from 200 to 400 patient results per hour. Additionally, the cobas c 513 analyzer will achieve this performance with the same footprint.
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. This feature will help save valuable time and laboratory resources, while ensuring high-quality results.
Furthermore, the cobas c 513 analyzer will provide a higher on-board test capacity. This will enable laboratories to load the analyzer with more tests at a time, save laboratory space, minimize lab resources and ensure a smooth workflow. The new analyzer will also offer closed tube sampling, which will reduce hands-on time, prevent sample contamination and ensure operator safety for laboratory personnel.