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

Rhea-AI Summary

Beckman Coulter Diagnostics has received FDA 510(k) clearance for its new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay system. The analyzer features:

• Throughput capacity of 800 clinical chemistry tests and 100 immunoassay tests per hour
• FlexMode operations for test prioritization
• Dynamic sample handler for automated repeats and re-runs
• Intuitive interface with proactive task indicators

The system is designed to support networked laboratory operational models, particularly relevant as approximately 45% of U.S. clinical laboratories (over 11,000) are part of Integrated Delivery Networks (IDNs). The analyzer has been available in CE mark countries since July 2024 and builds upon the previously released DxC 500 AU Chemistry Analyzer technology.

Positive

• FDA 510(k) clearance received for new integrated analyzer system
• High throughput capacity: 800 chemistry tests and 100 immunoassay tests per hour
• Automated sample handling and test prioritization capabilities
• Already commercially available in CE mark countries since July 2024

Negative

• None.

Insights

Financial Analyst

The FDA 510(k) clearance of Beckman Coulter's DxC 500i Clinical Analyzer represents a meaningful commercial milestone for Danaher's diagnostics segment. This integrated platform significantly enhances DHR's competitive positioning in the laboratory diagnostics market, particularly for serving the 11,000+ U.S. laboratories operating within Integrated Delivery Networks (45% of all clinical labs).

The strategic value extends beyond the initial equipment sales. By maintaining common reagents and consumables across its analyzer portfolio, Beckman Coulter is strengthening its consumables business - the true profit engine in diagnostic instrumentation. This creates a classic razor/razor blade model with predictable, high-margin recurring revenue streams.

The timing is particularly favorable as healthcare networks increasingly adopt centralized laboratory models seeking operational efficiencies. The DxC 500i's dual functionality (chemistry and immunoassay) directly addresses this market shift by offering consolidated testing capabilities with substantial throughput (800 chemistry tests and 100 immunoassay tests hourly).

Having already launched in CE-mark countries since July 2024, Beckman Coulter has had time to refine deployment strategies and address early implementation challenges before entering the important U.S. market. This approval complements Danaher's broader portfolio approach, building upon the previously released DxC 500 AU Chemistry Analyzer and providing customers with scalable solutions regardless of laboratory size or testing volume.

Healthcare Technology Specialist

The DxC 500i's FDA clearance significantly strengthens Beckman Coulter's competitive position in the evolving laboratory automation landscape. The system's technical specifications address several critical pain points facing modern clinical laboratories.

The integration of both chemistry and immunoassay testing on a single platform is particularly valuable given current laboratory staffing challenges. The analyzer's FlexMode operations and dynamic sample handling capabilities enable intelligent test prioritization and automated sample management - reducing manual intervention and allowing labs to operate more efficiently with existing personnel.

From a laboratory workflow perspective, the system's intuitive interface with proactive task indicators and step-by-step instructions directly addresses training barriers, enabling faster onboarding of new personnel - important as laboratories face ongoing staffing shortages and high turnover rates.

The standardization of reagents across Beckman Coulter's analyzer portfolio delivers substantial operational benefits for Integrated Delivery Networks. Common reference ranges eliminate the need for result normalization across networked facilities, enhancing result consistency and potentially reducing diagnostic variability. Additionally, inventory standardization across multiple facilities offers procurement efficiencies and reduces supply chain complexity.

By incorporating the Six Sigma performance standards from its DxC 500 AU technology, Beckman Coulter is maintaining analytical quality while expanding functionality - a critical consideration for laboratories where result accuracy remains paramount regardless of throughput demands.

The new DxC 500i Analyzer Offers Flexibility and Scalability with
Broad Chemistry and Immunoassay Assay Menu

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).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," 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."

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.

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About Beckman Coulter Diagnostics

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time — and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and to optimize lab performance services. Headquartered in Brea, Calif., with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher (NYSE: DHR). Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow's science and technology to improve human health.

© 2025 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. The Danaher trademark is a proprietary mark of Danaher Corporation. All other trademarks are the property of their respective owners. 2025-14088

ⁱ Beckman Coulter Diagnostics internal data on file

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SOURCE Beckman Coulter Diagnostics

FAQ

What are the throughput capabilities of Beckman Coulter's new DxC 500i Clinical Analyzer?

The DxC 500i can process up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour.

When did the DxC 500i Clinical Analyzer receive FDA clearance?

The DxC 500i Clinical Analyzer received FDA 510(k) clearance in March 2025.

How many U.S. clinical laboratories are part of Integrated Delivery Networks (IDNs)?

Approximately 45% of U.S. clinical laboratories (over 11,000 labs) are associated with IDNs.

What key features does the DxC 500i Clinical Analyzer offer for laboratory operations?

It offers FlexMode operations for test prioritization, dynamic sample handling for automated repeats and re-runs, and an intuitive interface with step-by-step instructions.