FDA Clearance for DxC 500 AU Chemistry Analyzer
Beckman Coulter Diagnostics, a leading provider of clinical diagnostics, has obtained FDA clearance for its latest product, the DxC 500 AU Chemistry Analyzer. This automated chemistry analyzer expands the company's clinical chemistry offerings and reflects their ongoing dedication to innovation in the in vitro diagnostic industry.
The DxC 500 AU Chemistry Analyzer is specifically designed for small-to-medium-sized laboratories, offering a solution to optimize workflows and aid critical clinical decisions.
An important feature of the DxC 500 AU Chemistry Analyzer is its use of standardized assays and reagents, which are consistent with Beckman Coulter's portfolio of AU clinical chemistry analyzers.
This uniformity ensures timely and accurate patient results for both independent laboratories and those within integrated networks, providing consistent and harmonized outcomes across AU platforms to aid clinical decision-making and improve patient outcomes.
Kathleen Orland, Senior Vice President and General Manager for Chemistry and Immunoassay at Beckman Coulter Diagnostics, expressed her satisfaction with the expansion of their reliable clinical
chemistry series. "In addition to delivering commutable patient results across low-to-high-volume chemistry platforms, using the same reagents has a positive impact on inventory and cost across a health system," she stated.
The DxC 500 AU Chemistry Analyzer has undergone rigorous assessments, including Six Sigma metrics, and meets or exceeds the demanding CLIA 2024 performance specifications, as confirmed by Sten Westgard, Director of Client Services and Technology for Westgard QC.
In the medical field, diagnostic testing influences 70% of medical decisions, highlighting the importance of accuracy and reliability in test results. The DxC 500 AU Chemistry Analyzer offers a broad menu of 120-plus assays, which have been independently and objectively verified for quality performance, instilling confidence in the integrity of the results.
Please note that the DxC 500 AU Chemistry Analyzer is intended for in vitro diagnostic use only.
Note: Content may be edited for style and length.
Source
