FDA grants 510(k) approval for Aurora Xi Plasmapheresis System. - Fresenius Kabi
Fresenius Kabi announced it has received FDA 510(k) clearance for the Aurora Xi Plasmapheresis System.
The Aurora Xi Plasmapheresis System, comprises the Aurora Xi instrument (hardware and software) and a PLASMACELL Xi Disposable Set and is an automated plasmapheresis system intended for routine collection of virtually cell-free plasma to be processed as Source Plasma. The Aurora Xi system, like the predicate Aurora system, uses a rapidly rotating separator (membrane filter) to separate whole blood into plasma for collection and concentrated cells for reinfusion to the donor.
"The Aurora Xi system features a proprietary filtration-separation method that enables the faster collection of Source Plasma. The system helps to improve plasma center efficiency and the overall experience for operators and donors,� said Dean Gregory, president, medical devices, Fresenius Kabi USA. �Faster collection times mean more throughput for our customers, helping maximize the volumes of plasma they collect while assuring a good experience for plasma donors.�
Comment: The original Aurora system was cleared under 510(k) BK110072 on29 March 2012.
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