Designed for small-to-medium-sized laboratories, DxC 500 AU is intended to improve laboratory workflows and support critical clinical decisions using standardised assays and reagents
Beckman Coulter has received FDA clearance for its new DxC 500 AU Chemistry Analyzer. (Credit: PR Newswire/Beckman Coulter, Inc.)
Beckman Coulter Diagnostics has received clearance from the US Food and Drug Administration (FDA) for its new automated DxC 500 AU Chemistry Analyzer.
The US-based diagnostics solutions provider has designed the automated chemistry analyser for small-to-medium-sized laboratories.
Cleared by the FDA for only in vitro diagnostic use, DxC 500 AU is intended to improve laboratory workflows and support crucial clinical decisions. The analyser also expands the company’s clinical chemistry portfolio.
According to Beckman Coulter Diagnostics, DxC 500 AU uses standardised assays and reagents present in the company’s portfolio of AU clinical chemistry analysers.
The standardised assays and reagents enable timely and accurate patient results for independent laboratories as well as those part of integrated networks, said the company.
The chemistry analyser delivers consistent, harmonised results across AU platforms for clinical decision-making and patient outcomes, the diagnostics solutions provider added.
Beckman Coulter Diagnostics said that the wide range of assays available on the DxC 500 AU Chemistry Analyzer has been verified independently and objectively for quality performance to support confidence in the integrity of the results.
Beckman Coulter Diagnostics chemistry and immunoassay general manager and senior vice president Kathleen Orland said: “We are pleased to expand our offering of reliable clinical chemistry series.
“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.”
In a separate development, the company unveiled its DxI 9000 Access Immunoassay Analyzer for the first time in North America.
The analyser is intended to address clinical laboratory demands for speed, reliability, reproducibility, quality, and expansion of menu.
In February this year, Beckman Coulter Diagnostics announced a partnership with MeMed to co-develop and commercialise the latter’s MeMed BV test, a host immune response diagnostic.