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The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coaqulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coaqulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor.

The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.

The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.

The VisuCal-F Frozen Calibrator Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The VisuCon-F Frozen Normal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The VisuCon-F Frozen Abnormal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.

The provided document describes three devices: VisuCal-F Frozen Calibrator Plasma, VisuCon-F Frozen Normal Control Plasma, and VisuCon-F Frozen Abnormal Control Plasma. However, the document does not contain an acceptance criteria table or performance study results for any of these devices. Instead, it provides a comparison of the proposed devices to predicate devices to establish substantial equivalence based on similar intended use, product matrix, and performance characteristics.

Therefore, I cannot fulfill your request for an acceptance criteria table or details of a study that proves the device meets specific acceptance criteria. The document focuses on establishing substantial equivalence for regulatory purposes rather than presenting detailed performance data against predefined acceptance criteria.

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