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The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.

SECQUIRE Cell Separator

The provided text is a 510(k) premarket notification letter from the FDA to Smith Associates regarding the SECQUIRE Cell Separator. This document is a regulatory approval letter and does not contain information about acceptance criteria or the study data proving the device meets those criteria.

The letter states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for its stated indications for use (preparation of low volume platelet rich plasma and platelet poor plasma at the point of care). However, it explicitly mentions a limitation: "The safety and effectiveness of this device for in vivo indications for use has not been established."

Therefore, based solely on the provided text, I cannot complete the requested table or answer the questions about acceptance criteria and study details. This information would typically be found in the 510(k) submission itself, including the detailed reports of performance studies, which are not part of this FDA clearance letter.

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