The approval has been granted for a labeling change, which allows blood centers to use the Fenwal Amicus system for the storage of Amicus-derived platelets in plasma for up to seven days.
Fresenius Kabi North America medical devices president Dean Gregory said: "Our customers now have the ability to store and use seven-day platelets processed by Amicus to help meet an important need in transfusion medicine.
"We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice."
The Fenwal Amicus system is a cell separation system developed for hospitals and blood centers to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells used for therapeutic applications and clinical research.
To support this requirement, Fresenius Kabi will exclusively distribute Verax Platelet PGD test, a rapid platelet PGD test that received FDA approval as a safety measure" for leukoreduced apheresis platelets within 24 hours prior to transfusions.
