Platelet-rich plasma (PRP) Tube FDA Compliance Testing
Project Description
MULTIPLE TESTING
FDA GMP Bioanalytical Laboratory needed for FDA 510(k) predicate device comparison testing on Platelet-rich plasma (PRP) tube which is used to separate PRP from human peripheral blood by centrifuge separation. The following test items need to be performed compared with the predicate device to meet the FDA request on the PRP after centrifuge. Testing needs to be performed asap. Thank you!
The predicate device manufacturer included a side-by-side comparison of the platelet concentrates to show equivalence in the following tests:
? Platelet Concentration Factor
? Platelet Yield
? pH
? Platelet activation
? Platelet Aggregation
? Hypotonic Stress Response
? White Blood Cell, Red Blood Cell, Hematocrit, and Platelet counts
? Bone Graft Retention
Project Information
Number:23-01336
Industry:Healthcare and Medical
