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Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The Tina-quant IgG Gen.2 is an immunoturbidimetric assay. Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

This is a request for information about a 510(k) submission for a medical device called "Tina-quant IgG Gen.2". The provided text is a 510(k) summary and the FDA's clearance letter. The document does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The text describes an immunoturbidimetric assay for measuring IgG in human serum and plasma. It compares the new device (Tina-quant IgG Gen.2) to a predicate device (Tina-quant IgG, K955906) and highlights similarities and differences, primarily in measuring range and expected values for different age groups.

Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory filing, not a scientific study report detailing performance metrics against specific acceptance criteria.

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