Product Classification

• Device: platelet and plasma separator for bone graft handling
• Definition: Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
• Physical State: May include centrifuge, filters, tubes, syringes and needles
• Technical Method: Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet rich plasma is withdrawn.
• Target Area: Blood drawn from peripheral veins, PRP applied to bony defects
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: ORG
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• Regulation Number: 864.9245
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 19-42 IEC 61326-1 Edition 3.0 2020-10
  Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

Third Party Review

Not Third Party Eligible