21 CFR 864.9245 — Separator, Automated, Blood Cell, Diagnostic
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9245
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | 2 | 10 | |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | 2 | 0 | |
| PKG | Bone Marrow Processing Device To Support Hematopoietic Reconstitution | 2 | 0 | |
| PMQ | Peripheral Blood Processing Device For Wound Management | 2 | 0 |
Special Controls
GKT — Separator, Automated, Blood Cell, Diagnostic
*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.”
eCFR
GKT — Separator, Automated, Blood Cell, Diagnostic
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.”
Ecfr Llm
ORG — Platelet And Plasma Separator For Bone Graft Handling
*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.”
eCFR
PKG — Bone Marrow Processing Device To Support Hematopoietic Reconstitution
*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.”
eCFR
PMQ — Peripheral Blood Processing Device For Wound Management
*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.”
eCFR
