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The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems. Blood coagulation instruments and test systems are used in hospitals and/or catherization labs. The AQC-LP is used as a control when the Actalyke system monitors moderately heparinized patients undergoing ECMO procedures or renal dialysis. The AQC-HP is used for QC testing when the Actalyke system is monitoring normal and highly heparinized patients undergoing cardiovascular procedures.

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This document section appears to be an FDA 510(k) clearance letter for a medical device called "Actalyke® QC Kits QAC-HP, AQC-LP." It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding the acceptance criteria, device performance data, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The regulatory classification of the device.
• General controls and regulations applicable to the device.
• The intended use of the device: "The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems."

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided document. This type of detailed study data is typically found in the 510(k) submission itself or in separate technical reports, not usually in the FDA clearance letter.

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