FDA clears Beckman Coulter Life Sciences DxFLEX Flow Cytometer
Revolutionary APD detector technology enables larger antibody panels and simplifies compensation
7 Mar 2024
Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation, has received 510(k) clearance from the 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.
Praised for its sensitivity and resolution, the compact DxFLEX Flow Cytometer makes 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 content analysis with higher sensitivity to find dim populations. 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 CytExpert software lowers labor time and enables work to begin even for novice users. The 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.
