Summary:
Beckman Coulter Diagnostics’ DxC 500i Clinical Analyzer has received FDA 510(k) clearance, offering high-throughput clinical chemistry and immunoassay testing with advanced automation for improved laboratory efficiency.
Takeaways:
- High-Performance Testing – The DxC 500i delivers up to 800 chemistry and 100 immunoassay tests per hour, ensuring fast and accurate results.
- Support for Networked Labs – Designed to meet the needs of Integrated Delivery Networks (IDNs), it enhances efficiency, standardization, and resource management.
- User-Friendly Automation – Features like FlexMode operations and intuitive interfaces streamline workflow, minimize operator intervention, and simplify staff training.
Beckman Coulter Diagnostics, a clinical diagnostics provider, has 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.
US Healthcare Adopting Networked Lab Models
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).i 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,” says 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.”
DxC 500i Clinical Analyzer Prioritizes Immunoassay and Chemistry Testing
The DxC 500i Clinical Analyzer 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. Of equal importance, 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.
Prior to the DxC 500i Clinical Analyzer introduction, 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. The DxC 500i analyzer incorporates the DxC 500 AU technology within its clinical chemistry capabilities, including its Six Sigma performance.
Not all products are available in all countries. Product availability and regulatory status depends on country registration per applicable regulations.
Featured Image: 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. Featured Image: Beckman Coulter
Reference
i Beckman Coulter Diagnostics internal data on file
