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Beckman Coulter Life Sciences Flow Cytometer Nabs FDA 510(k) Clearance

NEW YORK – Danaher subsidiary Beckman Coulter Life Sciences announced Tuesday that its DxFlex Clinical Flow Cytometer has received 510(k) clearance from the US Food and Drug Administration. 

The instrument, which was launched in countries accepting the CE mark in 2020, offers up to 13 colors and allows additional detectors to be activated without the need to purchase additional hardware, Beckman Coulter said in a statement. The system uses avalanche photodiode detector technology, which "simplifies compensation procedures and delivers richer content analysis with higher sensitivity to find dim populations," the company added.

The compact platform is available in two configurations: a three-laser and 10-color system and a three-laser and 13-color configuration. However, in the US, the instrument is validated as an in vitro diagnostic device for 10-color immunophenotyping with the ClearLLab 10C Reagent system, the firm said. The instrument is CE-marked for 13-color in vitro diagnostic use. 

"The DxFlex Clinical Flow Cytometer adds more colors without adding more concerns and enables laboratory staff to have greater confidence in results, while streamlining workflows and reducing manual steps," Beckman Coulter Product Manager Carsten Lange said in a statement. "With more fluorescence parameters, laboratories can get more out of specimens and avoid a tedious compensation process and the burden that places on lab staff."