NEW YORK — Sysmex America said on Wednesday that it has received US Food and Drug Administration clearance for the addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode.
The analyzer received 510(k) clearance from the FDA about a year ago for red blood cell and platelet component testing, as well as with differential for whole blood samples.
With the latest clearance, it is now the only automated hematology analyzer to be FDA-cleared for residual white blood cell counting, the Lincolnshire, Illinois-based company said.
"Sysmex America's XN-10 Automated Hematology Analyzer with Blood Bank mode is a holistic solution that covers donors, patients, and blood components," Sysmex America CEO Andy Hay said in a statement. "The XN-10's standardized, consistent, and automated assessment of blood product quality ensures patient safety."
Sysmex America is a regional affiliate of Kobe, Japan-based Sysmex.