Danaher's Beckman Coulter Diagnostics Gets FDA Clearance For DxC 500i Clinical Analyzer

(RTTNews) - Beckman Coulter Diagnostics, the clinical diagnostics unit of science and technology firm Danaher Corp. (DHR), announced Monday that the new DxC 500i Clinical Analyzer received 510(k) clearance from the U.S. Food and Drug Administration.

The DxC 500i Clinical Analyzer is an integrated clinical chemistry and immunoassay analyzer. The analyzer, with throughput of up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour, delivers precise and reliable results critical for timely clinical decision-making.

It combines advanced technology with an intuitive user interface, ensuring that laboratories of all sizes can meet the growing demands of modern healthcare.

The DxC 500i analyzer incorporates the DxC 500 AU technology within its clinical chemistry capabilities, including its Six Sigma performance.

It features FlexMode operations, prioritizing immunoassay and chemistry testing according to each sample's urgency. The new dynamic sample handler manages repeats and re-runs without operator intervention and pulls in a new sample rack as soon as the previous rack is offloaded, optimizing rapid throughput in a compact footprint.

The company added that the DxC 500i Analyzer's intuitive interface supports even the newest users through proactive task indicators with step-by-step instructions, simplifying staff onboarding and training.

The DxC 500i Clinical Analyzer has been available in countries accepting CE mark since July 2024.

Kathleen Orland, Chief Portfolio Officer for Beckman Coulter Diagnostics, 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."

Before introducing the DxC 500i Clinical Analyzer, Beckman Coulter unveiled the DxC 500 AU Chemistry Analyzer, an automated clinical chemistry analyzer with onboard guided workflows, more than 120 assays, and standardized reagents for use across healthcare networks.

In pre-market activity on the NYSE, Danaher shares were losing around 1.1 percent to trade at $209.71.

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