The cobas c513 analyzer has been submitted to the US Food and Drug Administration (FDA) for approval as a dedicated, high-throughput HbA1c testing solution to help laboratories meet increasing testing needs for people with diabetes.
The cobas c513 analyzer from Roche (Basil, Switzerland) is based on the proven, trusted cobas technology developed in cooperation with Hitachi High-Technologies (HHT). The HbA1c test is a longer term measurement of blood sugar levels used to determine if a person has or is at risk of developing diabetes. Set to run on the established Tina-Quant HbA1c A1cDx Gen.3 test, which is also used across the Roche laboratory HbA1c portfolio, the cobas c513 will ensure high-quality results and comply with current guidelines and recommendations for HbA1c testing and measures A1c as defined by the IFCC.
cobas c513 features direct results reporting, thereby minimizing 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, cobas c513 will provide a higher on-board test capacity, enabling laboratories to load the analyzer with more tests at a time, save lab space, minimize resources, and ensure a smooth workflow.
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The cobas c513 analyzer provides throughput of up to 400 HbA1c patient results/hour, closed
tube sampling (CTS), and is standardized according to IFCC transferable to DCCT/NGSP
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Source: Roche
