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Performance Data
510(k) equivalence study conducted and the following mean results were achieved:
Platelet Concentration Factor at 0 Hours = 4.1 – 4.5x baseline
Platelet Concentration Factor at 1 Hour = 4.5 – 4.8x baseline
Platelet Recovery % at 1 Hour = 61%
RBC at 0 Hours = 0.01
RBC at 4 Hours = 0.01
pH at 0 Hours = 7.5
pH at 4 Hours = 7.65
Platelet Activation (Resting) at 0 Hours = 10.2%
Platelet Activation (Stimulated ADP) at 0 Hours = 96.3%
Platelet Aggregation at 0 Hours = 96.1%
Platelet Aggregation at 4 Hours = 95.8%
HCT at 0 Hours = 0.01%
HCT at 4 Hours = 0.01%
WBC at 0 Hours = 0.6
WBC at 4 Hours = 0.6