# K200530: AMICUS Separator System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Sep 11, 2020 after 193 days
- Product code: GKT (Separator, Automated, Blood Cell, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 864.9245
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K831004 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192150: AMICUS Separator System, Fresenius Kabi AG (2019) Summary page 6.

## Indications for use
Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following: The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702) The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702) The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615) The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615) The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615) The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615) The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect: • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)(BK960005, BK990009) • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol)(single, double or triple units) (BK090065) • Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039) • Mononuclear Cells (BK000047) • Plasma (BK960005, BK120041) o Fresh Frozen Plasma • Must be prepared and placed in a freezer at -18° C or colder within eight hours after phlebotomy. o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) • Must be stored at 1-6°C within eight 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. o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) 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. o Source Plasma The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post-platelet count greater than or equal to 100,000 platelets/microliter. Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units). The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to seven days. Additionally, for platelet units stored past five days and through seven days, every product must be tested with a bacterial device cleared by FDA and labeled as a “safety measure.”

Source page: https://510kreport.com/device/K200530
Methodology: https://510kreport.com/methodology