Beckman Coulter has received the US Food and Drug Administration (FDA) 510(k) approval for DxC 500i Clinical Analyzer, an advanced clinical chemistry and immunoassay analyser.

DxC 500i is designed to combine advanced technology with an intuitive user interface, allowing laboratories of all sizes to meet the increasing demands of modern healthcare.

The device has a throughput of up to 800 clinical chemistry tests and 100 immunoassay tests per hour, providing precise and reliable results for timely clinical decision-making.

Its FlexMode operations feature facilitates the prioritisation of immunoassay and chemistry testing based on each sample’s urgency.

Also, its dynamic sample handler helps manage repeats and re-runs without operator intervention and automatically pulls in a new sample rack after offloading the previous one.

The DxC 500i Clinical Analyzer optimises rapid throughput within a compact footprint and significantly enhances laboratory efficiency.

Beckman Coulter Diagnostics chief portfolio officer Kathleen Orland said: “Innovations like the DxC 500i Clinical Analyzer enable Beckman Coulter to address the needs of networked laboratories with specific solutions for satellite or independent laboratories, as well as core laboratories.

“Beyond ensuring appropriate throughput levels for a networked lab, Beckman Coulter’s common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio enables common reference ranges, offering IDNs strategic benefits in patient care and inventory management.”

DxC 500i’s user-friendly interface also supports new users through task indicators and step-by-step instructions, making staff onboarding and training easier.

Since July 2024, the DxC 500i Clinical Analyzer has been available in countries that accept the CE mark.

Its launch follows the DxC 500 AU Chemistry Analyzer, which features automated workflows, over 120 assays, and standardised reagents.

Furthermore, DxC 500i incorporates the DxC 500 AU technology, including its Six Sigma performance, within its clinical chemistry capabilities, said Beckman Coulter.