Beckman Coulter Life Sciences received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to distribute its DxFLEX Clinical Flow Cytometer in the United States.

Launched regionally in 2020, this advancement brings the benchtop IVD flow cytometry system to American labs while expanding testing capabilities. Offering up to 13-colors,* additional detectors can be activated as laboratory needs evolve without the need to purchase additional hardware.

“This pioneering advancement puts high-complexity flow cytometry testing within reach to more laboratories without added expense,” says Carsten Lange, product manager. “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. 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.”

The compact DxFLEX Flow Cytometer is designed to make multicolor flow cytometry less complex by using avalanche photodiode (APD) detector technology instead of traditional photomultiplier tube (PMT) technology. The use of APD technology simplifies compensation procedures and delivers richer content analysis with higher sensitivity to find dim populations, the company says. By comparison, running compensation on a conventional PMT flow cytometer involves significant hands-on time, even when features like auto-compensation setup are available in the software.

The dynamic compensation library simplifies compensation setup, while easy-to-learn CytExpert software lowers labor time and enables work to begin right out of the box for novice users. The compact DxFLEX Flow Cytometer is available in two configurations, from a three-laser/10-color system to a three-laser/13-color* configuration.

The DxFLEX Flow Cytometer is validated as an in vitro diagnostic device for 10-color immunophenotyping with the ClearLLab 10C Reagent System and delivers the only FDA cleared and CE marked integrated leukemia and lymphoma** solution, which offers all components needed, from quality controls, sample preparation and antibody panels to analysis software and training material. This enables workflows for diseases such as chronic leukemia, myeloma, acute leukemia, non-Hodgkin lymphoma, myeloproliferative neoplasm, and myelodysplastic syndrome, the company says.

Further reading: Beckman Coulter Unveils New Clinical Chemistry Analyzer

In addition to the United States, the DxFLEX Flow Cytometer is available in countries that accept the CE mark as the basis for their country-specific registration, including Europe, China, India and Japan

* DxFLEX is CE marked for 13-color in-vitro diagnostic use. In U.S., DxFLEX is intended for use as an in-vitro diagnostic device for 10-color immunophenotyping with ClearLLab 10C Reagent system. Fluorescence channels FL11 – FL13 and all other uses are for research use only.

** Non-Hodgkin Lymphoma only

Photo: Beckman Coulter Life Sciences