FDA WARNING_LETTER - Arteriocyte Medical Systems Inc

On December 23, 2009, the FDA issued a Warning Letter to Arteriocyte, Inc. regarding their Magellan Autologous Platelet Separator System (BK040068), STEM-PREP, and SPORT-PREP products. The FDA's Office of Compliance and Biologics Quality (OCBQ) reviewed Arteriocyte's website and found the firm was marketing the Magellan system for new intended uses without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act (the Act).

The Magellan system was cleared under 510(k) BK040068 for preparing platelet poor plasma and platelet concentrate (platelet rich plasma) from blood and bone marrow for diagnostic tests, and for mixing platelet rich plasma with autograft/allograft bone for orthopedic sites. The clearance explicitly required labeling stating, "The Platelet Rich Plasma prepared by this device has not been evaluated for any clinical indications," and that all labeling and promotional material refer to the output only as "Platelet Rich Plasma" or "PRP."

Arteriocyte's website listed "Magellan STEM-PREP" and "Magellan SPORT-PREP," suggesting the system prepares stem cells or has clinical indications in sports medicine, which are major changes to the cleared intended uses. This renders the Magellan system adulterated under section 501(f)(1)(B) and misbranded under section 50