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The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the quantitation of IgG and IgM anti-phosphatidylserine antibodies in human serum or delection and sem-quantiation of 180 and 125 and procession in the disorders (antiphospholipid syndrome).

REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit

The provided document is a 510(k) clearance letter from the FDA for the REAADS® anti-phosphatidylserine IgG/IgM Semi-quantitative Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information requested regarding:

1. Table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

The document is a regulatory approval, not a technical study report. To obtain the requested information, one would typically need to refer to the 510(k) submission summary, the device's Instructions for Use (IFU), or published clinical validation studies, none of which are included in this excerpt.

Therefore, I cannot provide the requested information from the given text.

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