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The Tina-Quant Hemoglobin A1c Gen. 2 assay is an in vitro diagnostic reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry analyzers. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

With the Tina-Quant Hemoglobin A1c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA1c by a turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbA1c from the HbA1c/Hb ratio according to a user selected protocol.

The provided document is a 510(k) Summary for the Tina-quant HbA1c Gen.2 Assay. It outlines the device's intended use and compares it to a predicate device but does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against these criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (K072714) by comparing features and intended uses. It lists some analytical characteristics like precision and sensitivity, but these are presented as inherent features of the device rather than results of a specific study proving acceptance criteria.

To answer your request thoroughly, I would need a different type of document, such as a full study report or a detailed validation section, that explicitly states acceptance criteria and presents data demonstrating that the device meets them.

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