BK251274- RegenBMC® (RegenKit®-THT®-BMC)
The FDA has documented the indications for the RegenBMC® (RegenKit®-THT®-BMC) system, which is designed for the intraoperative preparation of autologous platelet concentrate from peripheral blood or a combination of peripheral blood and bone marrow.
The manufacturer, Regen Lab SA, and clinical staff involved in point-of-care autologous blood processing and intraoperative regenerative medicine procedures.
This indication confirms the regulatory pathway for a system that bridges traditional PRP preparation with bone marrow aspirate processing at the point-of-care. The specific focus on intraoperative use and 'rapid' preparation suggests that the device meets safety and performance standards for real-time surgical application, requiring rigorous adherence to aseptic processing and standardized mixture protocols.
Regulatory teams should ensure that point-of-care labeling and IFUs strictly align with the specific blood-to-bone-marrow mixture ratios cleared. Operations teams should verify that intraoperative protocols reflect the 'safe and rapid' preparation standards referenced in the indication.
The RegenBMC® system is indicated to be used intraoperatively at the point-of-care for the safe and rapid preparation of autologous platelet concentrate platelet-rich plasma (PRP) from a small sample of peripheral blood or a mixture of peripheral blood and bone marrow.
Open in openFDA / FDA.gov