FDA OKs Beckman Coulter’s DxC 500 AU Chemistry Analyzer

Beckman Coulter Diagnostics has earned U.S. Food and Drug Administration (FDA) clearance for its DxC 500 AU chemistry analyzer, an automated chemistry analyzer.
 
DxC 500 is designed for small-to-medium-sized labs and aims to optimize workflows and support critical clinical decisions. It uses standardized assays and reagents to facilitate timely, accurate results that are harmonized across AU platforms.
 
“We are pleased to expand our offering of reliable clinical chemistry series,” Kathleen Orland, Senior Vice President, Business Unit, General Manager Chemistry and Immunoassay for Beckman Coulter Diagnostics, told the press. “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,” added Sten Westgard, Director of Client Services and Technology for Westgard QC.
 
DxC 500 has a menu of 120-plus assays. Its menu has been independently and objectively verified for quality performance, according to the company.