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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