Beckman Coulter Announces FDA clearance of DxC 500i Clinical Analyzer, an integrated Clinical Chemistry and Immunoassay System

BREA, Calif., March 10, 2025 /PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, today announced that the new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer, received 510(k) clearance from the U.S. Food and Drug Administration. The DxC 500i combines advanced technology with an intuitive user interface, ensuring that laboratories of all sizes can meet the growing demands of modern healthcare. With throughput of up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour, this analyzer delivers precise and reliable results critical for timely clinical decision-making.

Healthcare systems around the world and specifically in the United States are strategically adopting networked laboratory operational models for better efficiency and patient access. Approximately 45% of clinical laboratories in the United States — a total of more than 11,000 labs — are associated with an Integrated Delivery Network (IDN).IDNs are organizations that provide a coordinated range of healthcare services, including diagnostic testing allowing for better resource management, standardized practices, and enhanced quality of care.

“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,” said Kathleen Orland, Chief Portfolio Officer for Beckman Coulter Diagnostics. “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.”

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