DxC 500 AU Chemistry Analyzer Receives FDA Clearance

DxC 500 AU Chemistry Analyzer Receives FDA Clearance Beckman Coulter Diagnostics, a leader in clinical diagnostics, has obtained FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer that expands the company's product range in clinical chemistry and demonstrates its commitment to product innovation in the in vitro diagnostics sector. Designed for small and mid-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several new 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 in Beckman Coulter's AU clinical chemistry analyzer portfolio. The use of standardized assays and reagents facilitates timely and accurate patient results for both independent laboratories and those that are part of integrated networks, delivering consistent and compatible results across AU platforms for clinical decision-making and patient outcomes. Kathleen Orland, Senior Vice President, Business Unit, General Manager of Chemistry and Immunoassay at Beckman Coulter Diagnostics, said, "We are pleased to expand our reliable clinical chemistry series offering. In addition to interchangeable patient results across low to high-volume chemistry platforms, the application of the same reagents has a positive impact on inventory and costs across a healthcare system." Sten Westgard, Director of Customer Service and Technology at Westgard QC, said, "The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer, evaluated with Six Sigma metrics, meets and/or exceeds many of the requirements of the CLIA 2024 performance specifications." Diagnostic tests drive 70% of medical decisions1, and with increasing demand for improved accuracy and reliability of results, the DxC 500 AU Chemistry Analyzer's broad menu of over 120 assays supports confidence in result integrity, independently and objectively verified for quality performance. The DxC 500 AU Chemistry Analyzer is for in vitro diagnostic use only.   Source