US FDA clears Beckman Coulter Life Sciences DxFLEX Flow Cytometer

Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation, has received 510(k) clearance from the US Food and Drug Administration (FDA) to distribute its DxFLEX Clinical Flow Cytometer in the United States (US).

Launched regionally in 2020, this advancement brings the popular 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 superior 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 richer 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.

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.