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510(k) Substantial Equivalence Determination Decision Memorandum Assay and Instrument Combination Template. K163633

510(k) Substantial Equivalence Determination Decision Memorandum Assay and Instrument Combination Template. K163633 2025

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The document is a 510(k) decision summary for the cobas HbA1c Test, a new in vitro diagnostic device developed by Roche Diagnostics Operations. It quantitatively measures glycated hemoglobin (HbA1c) in whole blood using latex agglutination inhibition methodology on the cobas b 101 system. The test is intended for professional use in clinical laboratories and point-of-care settings to monitor long-term blood glucose control in patients with diabetes, but not for screening or diagnosing diabetes. The document outlines regulatory information, intended use, device description, performance characteristics, and substantial equivalence to the predicate device Siemens DCA Vantage.

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