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Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.

Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent for the specific correction of Lupus Anticoagulants.

This product is for in-vitro diagnostic use only.

Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent for the specific correction of Lupus Anticoagulants.

The provided text is a 510(k) premarket notification summary for a medical device called "Frozen Format LA Confirm." It's a regulatory document from the FDA, not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

This document primarily indicates that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device for its stated indications for use, thereby allowing DSRV, Inc. to market it. It discusses regulatory compliance and general controls, but not the specific technical performance data or study details required to fill out the requested table and answer the questions.

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