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FDA Grants 510(k) Clearance for Fresenius Kabi’s Adaptive Nomogram

New algorithm increases plasma collection while maintaining donor safety.

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By: Charlie Sternberg

Associate Editor

Fresenius Kabi receives FDA 510(k) clearance for an Adaptive Nomogram developed to enhance plasma collection efficiency with the company's Aurora Xi plasmapheresis system.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Fresenius Kabi’s Adaptive Nomogram, an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System designed to optimize plasma collection efficiency. The newly cleared Adaptive Nomogram considers each donor’s individual characteristics in calculating the volume of plasma to collect, enabling an average 11.5% increase in plasma collection per donation while maintaining safe and effective operatio...

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