NEW YORK (360Dx) – Beckman Coulter today announced it has filed a 510(k) application with the US Food and Drug Administration for clearance of its Early Sepsis Indicator.
The hematology-based solution is intended to provide clinicians information about sepsis and the risk of developing sepsis in patients in acute care settings. It is offered as part of a standard complete blood count with differential test, Beckman Coulter said, adding results can be achieved in less than one hour without additional workflow burden for clinicians or clinical labs.
The CE-marked technology is for use with the company's DxH 900 hematology analyzer, which offers near native-state cellular characterization. The platform, intended for mid- to high-volume clinical laboratories, leverages Beckman Coulter's VCS360 technology to detect morphological changes in monocytes, which can provide insight into possible sepsis earlier than with other indicators, according to the firm.