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Sysmex Sees ADCC Downclassification As Smoothing Path To HPC Indication

This article was originally published in The Gray Sheet

Executive Summary

Sysmex Corporation expects the new Class II designation for automated differential cell counters (ADCCs) used to count and classify abnormal cells in the blood will facilitate the firm's quest to expand labeling for its SE series automated hematology analyzer.

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Sysmex XE-2100

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)...

Sysmex XE-2100

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)...

Differential cell counters

Automated systems will be reclassified from Class III to Class II with special controls based on information submitted in a reclassification petition by the International Society for Laboratory Hematology, FDA proposes in a May 9 Federal Register notice. FDA had previously rejected a downclassification submission filed by Abbott (1"The Gray Sheet" Jan. 25, 1999, p. 8). The guidance "Automated Differential Cell Counters for Immature or Abnormal Blood Cells" will serve as a special control. Comments are due by Aug. 7

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