Beckman Coulter’s DxC 500i clinical analyzer gains FDA clearance

USA – Beckman Coulter Diagnostics, a division of Danaher Corporation, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest innovation, the DxC 500i Clinical Analyzer.

This integrated clinical chemistry and immunoassay analyzer is designed to improve efficiency in laboratories, offering precise and reliable test results that support faster clinical decision-making.

The DxC 500i can perform up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour, making it a high-throughput solution for laboratories of all sizes.

By combining advanced technology with an intuitive user interface, the analyzer ensures efficient sample processing, helping labs meet the increasing demands of modern healthcare.

Kathleen Orland, Chief Portfolio Officer at Beckman Coulter Diagnostics, emphasized the significance of this innovation: “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.”

Smart features for improved workflow

The DxC 500i incorporates DxC 500 AU technology within its clinical chemistry capabilities, ensuring high-performance results with Six Sigma-level precision.

It features FlexMode operations, which prioritize immunoassay and chemistry tests based on sample urgency.

A key innovation in the DxC 500i is the dynamic sample handler, which automatically manages repeats and re-runs without requiring manual intervention.

It also loads new sample racks as soon as the previous ones are offloaded, ensuring continuous and optimized workflow.

Additionally, the user-friendly interface simplifies training for new staff. The system provides step-by-step instructions and proactive task indicators, making it easier for laboratories to onboard and train employees efficiently.

Global availability and market impact

The DxC 500i Clinical Analyzer has been available in countries that accept the CE mark since July 2024. Its FDA clearance now allows it to enter the U.S. market, expanding access to more healthcare facilities worldwide.

This approval builds on Beckman Coulter’s previous success with the DxC 500 AU Chemistry Analyzer, which features guided workflows, over 120 assays, and standardized reagents designed to work seamlessly across healthcare networks.

Orland highlighted the strategic advantages of the DxC 500i: “Beyond ensuring appropriate throughput levels for a networked lab, Beckman Coulter’s common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio enable common reference ranges, offering IDNs strategic benefits in patient care and inventory management.”

Following the announcement, Danaher’s shares saw a slight decline, dropping 1.1% in pre-market trading on the NYSE to US $209.71.

However, with the FDA clearance, the DxC 500i is expected to contribute to long-term growth in the clinical diagnostics sector.