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CryovCheck™ LA Sure™ dilute Russell's Viper Venom Test (dRVVT) is a high concentration phospholipid reagent intended for use in a confirmatory test to verify the presence of lupus anticoagulants (LA) in human plasma. Once LA is suspected by a prolonged result with the Cryov Check™ LA Check™ screening (low concentration phospholipid) reagent, LA Sure may then be used concomitantly to establish a ratio (LA Check/LA Sure) useful in discriminating between LA positive and LA negative specimens.

Cryo Check™ LA Sure™ dilute Russell's Viper Venom Test (dRVVT) is a high concentration phospholipid reagent.

I am sorry, but based on the provided text, there is no information regarding the acceptance criteria, device performance study, sample sizes, expert involvement, or any other details typically found in a clinical study report.

The document is a 510(k) clearance letter from the FDA for a device called "Cryo Check™ LA Sure™." This letter indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, meaning it can be marketed for the stated indications for use.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence, not necessarily on presenting detailed performance data from a specific study against acceptance criteria in the format you've requested. The letter mentions "indications for use" and "general controls provisions of the Act" but does not contain the kind of technical performance data you are looking for.

Therefore, I cannot provide the requested table or answer any of the specific questions about studying and data provenance because that information is not present in the provided text.

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