Beckman Coulter Receives FDA Clearance for DxC 500 AU Chemistry Analyzer, Expanding Portfolio with Proven Six Sigma Performance

Rhea-AI Summary

Beckman Coulter Diagnostics has received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer. The analyzer is designed for small-to-medium-sized laboratories and uses standardized assays and reagents across Beckman Coulter's portfolio of AU clinical chemistry analyzers. It has a broad menu of 120-plus assays and has been independently verified for quality performance. Diagnostic testing guides 70% of medical decisions, and the DxC 500 AU Chemistry Analyzer aims to improve accuracy and reliability of results.

Positive

• Beckman Coulter Diagnostics has expanded its clinical chemistry offering with the FDA clearance for the DxC 500 AU Chemistry Analyzer.
• The analyzer is designed for small-to-medium-sized laboratories, optimizing laboratory workflows and supporting critical clinical decisions.
• It uses standardized assays and reagents found across Beckman Coulter's portfolio of AU clinical chemistry analyzers, delivering consistent and harmonized results.
• The DxC 500 AU Chemistry Analyzer has a broad menu of 120-plus assays that have been objectively verified for quality performance.
• The analyzer aims to improve accuracy and reliability of results, supporting confidence in result integrity.

Negative

• None.

ANAHEIM, Calif., July 25, 2023 /PRNewswire/ -- Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to optimize laboratory workflows and support critical clinical decisions.

The DxC 500 AU Chemistry Analyzer uses standardized assays and reagents found across Beckman Coulter's portfolio of AU clinical chemistry analyzers. Using standardized assays and reagents facilitates timely and accurate patient results for both independent laboratories and those part of integrated networks, delivering consistent, harmonized results across AU platforms for clinical decision-making and patient outcomes.

"We are pleased to expand our offering of reliable clinical chemistry series," said Kathleen Orland, Senior Vice President, Business Unit, General Manager Chemistry and Immunoassay for Beckman Coulter Diagnostics. "In addition to commutable patient results across low-to high-volume chemistry platforms, application of the same reagents has a positive impact on inventory and cost across a health system."

"The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer, assessed by Six Sigma metrics, meets and/or exceeds the many demands of CLIA 2024 performance specifications," stated Sten Westgard, Director of Client Services and Technology for Westgard QC.

Diagnostic testing guides 70% of medical decisions¹ and with increased demand for improved accuracy and reliability of results, the DxC 500 AU Chemistry Analyzer's broad menu of 120-plus assays has been independently and objectively verified for quality performance, supporting confidence in result integrity.

The DxC 500 AU Chemistry Analyzer is for in vitro diagnostic use only.

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About Beckman Coulter. Inc.

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 80 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 optimize lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif., it has more than 11,000 global team members.

1 https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html 

©2023 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. 2023-11985

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SOURCE Beckman Coulter, Inc.

FAQ

What is the name of the company mentioned in the press release?

The company mentioned in the press release is Beckman Coulter Diagnostics.

What is the name of the new chemistry analyzer?

The new chemistry analyzer is called the DxC 500 AU Chemistry Analyzer.

What is the main benefit of using standardized assays and reagents?

Using standardized assays and reagents facilitates timely and accurate patient results, delivering consistent, harmonized results across AU platforms for clinical decision-making and patient outcomes.

What is the menu size of the DxC 500 AU Chemistry Analyzer?

The DxC 500 AU Chemistry Analyzer has a broad menu of 120-plus assays.

What percentage of medical decisions does diagnostic testing guide?

Diagnostic testing guides 70% of medical decisions.