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Sysmex XE-2100

This article was originally published in The Gray Sheet

Executive Summary

Hematopoietic progenitor cell (HPC) parameter of the IMI channel on the automated hematology analyzer gains 510(k) clearance. The parameter is used to screen for the optimal presence of HPCs in peripheral blood and cord blood samples. HPC enumeration "can be used to predict the optimal time to harvest stem cells in patients undergoing mobilization for autologous or allogeneic stem cell transplants," Sysmex explains. The XE-2100 is distributed by Roche Diagnostics in North America. The automated differential cell counter extended differential parameter clearance is the first by FDA since reclassification of ADCCs, effective Feb. 13, following a recommendation by FDA's Hematology and Pathology Devices panel in January 1999 (1"The Gray Sheet" Jan. 25, 1999, p. 8)...

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