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Cryo✓Check™ LA Check™ dilute Russell's Viper Venom Test (dRVVT) reagent is a low concentration phospholipid reagent intended for use as a screening test for the presence of lupus anticoagulants (LA). It may be used in conjunction with CryovCheck™ LA Sure™ (a high concentration phospholipid confirmatory reagent) to establish a ratio (LA Check/LA Sure) useful in discriminating between LA positive and LA negative specimens.

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This document is a 510(k) clearance letter from the FDA for a device called "Cryo/Check™ LA Check" which is a diagnostic reagent for detecting lupus anticoagulants. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices..." This means the device was cleared because it was shown to be substantially equivalent to an already approved device, not necessarily by meeting specific, new acceptance criteria through a dedicated study detailed in this document.

Therefore, I cannot extract the requested information from the provided text. The document is essentially an approval letter based on "substantial equivalence," not a performance summary.

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