Beckman Coulter's DxC 500 AU Chemistry Analyzer Receives FDA Clearance

Beckman Coulter Diagnostics received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company’s clinical chemistry offering.

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.