Sam Brusco, Associate Editor03.05.24
Beckman Coulter Life Sciences has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its DxFLEX clinical flow cytometer.
DxFLEX was regionally launched in 2020. The clearance beings the benchtop IVD flow cytometry system to American labs. It offers up to 13 colors and additional detectors that can be activated as lab needs evolve—without the requirement of buying additional hardware.
DxFLEX uses avalanche photodiode (APD) detector technology instead of traditional photomultiplier tube (PMT) tech. APD tech, according to the company, simplifies compensation procedures and produces richer content analysis with higher sensitivity to find dim populations.
The compact flow cytometer is available in two configurations: a three-laser/10-color system and three-laser/13-color configuration.
“This pioneering advancement puts high-complexity flow cytometry testing within reach to more laboratories without added expense,” said Carsten Lange, product manager at Beckman Coulter Life Sciences. “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 DxFLEX Flow Cytometer is validated as an IVD 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 provides all components needed, from quality controls, sample preparation, and antibody panels to analysis software and training material. This enables workflows for chronic leukemia, myeloma, acute leukemia, non-Hodgkin lymphoma, myeloproliferative neoplasm, and myelodysplastic syndrome.
DxFLEX was regionally launched in 2020. The clearance beings the benchtop IVD flow cytometry system to American labs. It offers up to 13 colors and additional detectors that can be activated as lab needs evolve—without the requirement of buying additional hardware.
DxFLEX uses avalanche photodiode (APD) detector technology instead of traditional photomultiplier tube (PMT) tech. APD tech, according to the company, simplifies compensation procedures and produces richer content analysis with higher sensitivity to find dim populations.
The compact flow cytometer is available in two configurations: a three-laser/10-color system and three-laser/13-color configuration.
“This pioneering advancement puts high-complexity flow cytometry testing within reach to more laboratories without added expense,” said Carsten Lange, product manager at Beckman Coulter Life Sciences. “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 DxFLEX Flow Cytometer is validated as an IVD 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 provides all components needed, from quality controls, sample preparation, and antibody panels to analysis software and training material. This enables workflows for chronic leukemia, myeloma, acute leukemia, non-Hodgkin lymphoma, myeloproliferative neoplasm, and myelodysplastic syndrome.