Clinical Study

Verification Protocol For 1.042 G/Cm3 Shelf For Apc-60

Posted Date: Apr 18, 2024

  • Investigator: Jose Cancelas
  • Specialties:
  • Type of Study: Device

The objective of this study is to verify the performance of the 1.042 g/cm3 Shelf (test device: 514001-257) for the APC-60 procedure pack against the predicate (original shelf: 514001-188) in a paired design. This paired experimental design is in accordance with FDA direction of in vitro testing of platelet rich plasma (PRP) processed from human blood products. The test device is designed to provide an improvement to the predicate device with respect to RBC contamination into the PRP.

Criteria:

Healthy Volunteer Donors Who Have Consented To Donate Blood Components For Laboratory Research Will Undergo Either A Whole Blood Donation

Keywords:

Platelet Rich Plasma, Blood Transfusion

For More Information:

Jose A Cancelas
15133760250
jose.cancelas@uc.edu