Beckman Coulter gains FDA clearance for UniCel DxH v3.0 software

Sept. 26, 2014

Beckman Coulter Diagnostics received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UniCel DxH v3.0 software, which supports automated connectivity of the UniCel DxH 800 and DxH Slidemaker Stainer COULTER Cellular Analysis Systems. The UniCel DxH Connected Workcell solution is now available for in vitro diagnostic use. The clearance enables laboratories to connect up to three DxH 800 analyzers to a DxH Slidemaker Stainer to create a customized, scalable workflow solution. The technology was CE Marked in March 2014 and is in use in 18 countries.

In combination with Beckman Coulter’s AIM technology, the workcell’s bi-directional sample transport system automatically distributes samples between the analyzers, reducing potential delays in sample testing and the reporting of results. The technology also allows for critical STAT samples or body fluids to be added while the system is running, without the need to interrupt routine sample testing.

User-defined decision rules for auto-rerun and reflex testing further improve workflow and reduce turnaround time. User-defined rules also drive automatic slide preparation and staining, without the need for manual intervention. Data management is also streamlined with information consolidated for order entry, results review (able to handle up to 90,000 results), and QC management (with a storage capacity for 30 control files, each with 150 runs per instrument).

Says Arnd Kaldowski, president, Beckman Coulter Diagnostics: “The DxH series demonstrates how Beckman Coulter offers solutions that help labs go beyond routine testing by automating processes to provide information that improves diagnosis in all areas of the laboratory—from hematology and urinalysis to chemistry  and immunoassay.” Learn more about diagnostics solutions from Beckman Coulter.

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