Beckman Coulter files a 510(k) submission for Early Sepsis Indicator

Beckman Coulter has filed a submission for 510(k) clearance with the USFDA for its Early Sepsis Indicator. The first-of-its-kind hematology-based solution is designed to give clinicians insight into the possibility of sepsis or risk of developing sepsis in patients in acute-care settings. The Early Sepsis Indicator is offered as part of a standard CBC with differential test. As such, test results can be available in less than 1 hour without additional workflow burden for clinicians or clinical laboratories. The Early Sepsis Indicator, which recently achieved the European CE Mark, is commercially available in select countries for use with the company’s newly released DxH 900 hematology analyzer.

The Early Sepsis Indicator uses the DxH 900 hematology analyzer’s enhanced Coulter technology, which offers near native-state cellular characterization. The company’s powerful VCS 360 technology can uniquely detect morphological changes in monocytes, cells that play a role in the dysregulated immune response to sepsis. Identifying these monocyte morphological changes provides insight into possible sepsis earlier than other indicators.

“We want to give clinicians in the emergency department a simple tool to help them identify sepsis quickly, shortening time to treatment for these critical patients.”

Peter Soltani
SVP and General Manager – Hematology Business,
Beckman Coulter