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Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers.

Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

The Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetric assay. Anti-CRP antibodies coupled to latex microparticles react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

The provided text is a 510(k) summary for the Tina-quant CRP (Latex) device. It describes the device's intended use, method, and comparison to a predicate device. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission for substantial equivalence to an existing device, and as such, it focuses on demonstrating that the new device is as safe and effective as the predicate device. It highlights similarities in intended use and methodology but also notes differences in measuring range and allowable plasma types. Crucially, it does not provide data from specific studies demonstrating performance against acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary.
2. Sample sizes used for the test set and the data provenance: Not detailed in the provided text.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not detailed in the provided text.
4. Adjudication method for the test set: Not detailed in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, including effect size: Not detailed in the provided text. This type of study is more common for diagnostic imaging AI, not for a quantitative immunoassay like this.
6. If a standalone performance study was done: The document describes the device itself but doesn't provide details on specific performance studies (like accuracy, precision, or linearity studies that would typically be performed).
7. The type of ground truth used: Not detailed in the provided text.
8. The sample size for the training set: Not applicable as this is a chemical assay, not an AI/machine learning device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The 510(k) summary focuses on establishing "substantial equivalence" to a predicate device (Roche Diagnostics Tina-quant CRP (Latex) HS assay, K003400) by comparing attributes like intended use, method, sample type, and measuring range. It explains that the modified device has an expanded measuring range compared to the predicate. The FDA's letter (pages 2-3) confirms the substantial equivalence determination but does not delve into the specific performance study details you are asking for.

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