Device Validation of In-vivo Performance Clinical Trial
Official title:
An In Vivo 24-Hour Recovery Study of Leukoreduced RBCs After Automated Separation of Whole Blood by the Reveos System and Storage for 42 Days
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
The Reveos® Automated Blood Processing System (Reveos system) is an automated whole blood processing system, not cleared for use in the United States. The Reveos System has been available outside the United States since 2012 and is seeking United States Food and Drug Administration (FDA) 510(k) clearance as an automated whole blood processor. The Reveos System is an integrated manufacturing system that processes whole blood (WB) units into blood components and is designed to minimize manual blood processing variables resulting from processing time, product and procedural variability. The Reveos System can simultaneously process up to 4 whole blood units into 4 RBC units, 4 leukoreduced plasma units, and 4 interim platelet units (IPU). The CPD/AS-5 RBC product is leukoreduced and may be stored up to 42 days. Terumo BCT is seeking 510(k) clearance from FDA/CBER for the Reveos® Automated Blood Processing System (Reveos System). The proposed study will provide validation on the in vivo performance of LR-RBC units derived from WB processed with the Reveos System. The results will provide data as to whether the Reveos System produced LR-RBC can maintain required levels of 24-hour in vivo recovery that meet FDA criteria for RBC. ;