Code of Federal Regulations Title 21. Food and Drugs § 21.864.9245 Automated blood cell separator

(a) Identification. An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.

(b) Classification. Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document:  Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”