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Immunoturbidimetric assay for the quantitative in vitro determination of IgA 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 IgA Gen.2 is an immunoturbidimetric assay. Anti-IgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the Tina-quant IgA Gen.2, focusing on demonstrating substantial equivalence to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance: While there's a table comparing the new device to the predicate in terms of intended use, method, sample type, measuring range, and expected values, these are not acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a direct report of the new device's performance against such criteria.
• Sample size and data provenance for a test set.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or related effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device (Tina-quant IgA, K955907) based on similarities in methodology, intended use, and slight modifications to the measuring range and expected values. It's a regulatory submission for clearance, not a detailed performance study report.

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