FDAnews Device Daily Bulletin

Fenwal’s Alyx Blood Collection System Lands 510(k) Approval for New Software

Nov. 25, 2013

The FDA has granted 510(k) clearance for next-generation software that allows collection of plasma alone on Fenwal’s Alyx blood collection system. The version 3.1 software builds on the capabilities of the Alyx system, which was FDA-cleared two years ago for the collection of either blood or a combination of blood and plasma.

Plasma samples collected using the Alyx system can be processed as fresh frozen plasma, plasma frozen within 24 hours after collection or plasma held at room temperature for 24 hours and then frozen, the Lake Zurich, Ill., company said.

By combining the new software with Fenway’s DXT Relay data exchange software, clinicians can set up procedures remotely and perform procedures without a need for paper documentation, Fenwal said.

The Alyx system and an added wireless data export feature were cleared by the FDA in December 2010. The DTX Relay software was cleared in August 2011.

The Alyx blood collection system is available worldwide. — Lena Freund

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