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This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

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The provided text is a 510(k) premarket notification document for a medical device. It is a regulatory approval, not a scientific study document. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document:

• Identifies the device: Human alpha-2-Macroglobulin kit for use on SPAPLUS.
• States its intended use: Quantitative in vitro measurement of alpha-2-Macroglobulin in human serum to aid in the diagnosis of blood-clotting or clot lysis disorders.
• Declares substantial equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, nor data provenance.
3. Information on experts or ground truth for the test set.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
6. Information on standalone algorithm performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific document. The information you're asking for would typically be found in a separate study report or technical documentation submitted as part of the 510(k) application, but it is not present in the FDA's decision letter itself.

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