ALYX 2RBC-LR Kit
Device Facts
| Record ID | BK230825 |
|---|---|
| Device Name | ALYX 2RBC-LR Kit |
| Applicant | Fresenius Kabi AG Lake Zurich, IL |
| Product Code | GKT · Hematology |
| Decision Date | Apr 5, 2024 |
| Decision | SESE |
| Regulation | 21 CFR 864.9245 |
| Device Class | Class 2 |
Indications for Use
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components. Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection system has been cleared for: Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as: Fresh Frozen Plasma Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy. Source Plasma Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy. Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. Collection of Plasma as: Fresh Frozen Plasma Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy. Source Plasma Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at -18°C or colder within 24 hours after phlebotomy. Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy. Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
Device Story
ALYX 2RBC-LR Kit is a sterile, single-use apheresis disposable kit; used with ALYX instrument; part of ALYX Component Collection System. System utilizes continuous-flow centrifugal separation to process whole blood into components. Kit includes fluid path, connectors, bags, and leukoreduction filter. Operated by trained personnel in blood collection establishments. Device separates whole blood into red blood cells and plasma; filter removes leukocytes. Output is collected blood components for clinical use. Modification involves substitution of leukoreduction filter component. Benefits include efficient collection of multiple blood products via automated process.
Clinical Evidence
Pivotal clinical study conducted in adults to evaluate the equivalence of the new leukoreduction filter to the current filter for the ALYX 2RBC-LR collection procedure. Primary and secondary endpoints met, providing evidence that the efficacy of the alternate filter is substantially equivalent to the predicate.
Technological Characteristics
Continuous-flow centrifugal blood cell separator. Single-use sterile fluid path kit including tubing, connectors, collection bags, and leukoreduction filter. System is an automated electromechanical instrument. No changes to fundamental technology or materials; modification limited to filter component substitution.
Indications for Use
Indicated for use in blood collection establishments for the collection and separation of whole blood into components, including leukoreduced or non-leukoreduced red blood cells and various plasma products (Fresh Frozen, Source, PF24, PF24RT24) in adult populations.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
- ALYX 2RBC-LR kit (BK200475)
