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This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

The Binding Site Human IgA Liquid Reagent Kit for use on the SPAPLUS is an immunoturbidimetric assy. Anti-IgA antibodies react with antigen in the sample to form antigen/antibody complex which is measured turbidimetrically.

The provided text describes a 510(k) summary for the Human IgA Liquid Reagent Kit for use on the SPAPLUS, but it does not contain a study proving the device meets specific acceptance criteria in the format requested. The document is an FDA submission for substantial equivalence to a predicate device, focusing on product description, intended use, and variations from the predicate.

Therefore, many of the requested data points (like sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies) are not present in the provided text, as they are typically associated with performance studies rather than substantial equivalence claims based on a comparison to an existing product.

However, I can extract the acceptance criteria as implied by the comparison to the predicate device and the modifications described. The 'reported device performance' is inferred from the modifications section, rather than explicit numerical results from a study.

Here's the information that can be extracted or inferred from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the claim of substantial equivalence to the predicate device and the improvements made. The "reported device performance" is the specifications of the modified device.

Study Details (Based on provided text)

1. Sample size used for the test set and the data provenance: Not mentioned. The document primarily focuses on a comparison to a predicate device and modifications, not a new clinical performance study with a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method for the test set: Not mentioned.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an in vitro diagnostic (IVD) kit, not an AI-assisted diagnostic tool that would involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an IVD kit, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For an IVD kit, ground truth would typically come from a reference method.
7. The sample size for the training set: Not applicable/Not mentioned. The document describes an immunoturbidimetric assay, which is a chemical reaction-based test, not a machine learning algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable/Not mentioned. As above, this is not a machine learning device.

Additional Information from the document:

• Predicate Device: Roche IgA Tina Quant Gen 2. on the Modular P (K040435).
• Modifications mentioned:
  • Added a low-level range (0.02-0.7g/L) for immunodeficiency determination, as recommended by ESID guidelines (below 0.2g/L, optimally down to 0.07g/L).
  • Sample volume changed from 25 µL to 8µL to allow neat sample runs.
  • Antigen excess capacity improved to 40g/L (from 30g/L in predicate).
• Fundamental scientific technology: Unchanged.

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