Beckman Coulter DxA 5000 gets 510(k) clearance

Oct. 11, 2019–Beckman Coulter announced that its DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is available for sale in the United States.

The DxA 5000 aims to help eliminate preanalytical errors by automatically detecting patient tube parameters such as sample identification, tube type, orders pending, and tube weight in the first three seconds. It screens each sample at multiple points and alerts laboratorians if action is needed, and it reduces the number of manual steps in sample processing from 32 to four. By understanding the tests requested, sample volume available, and real-time analyzer capacity and status, the system continuously calculates the most expeditious route for stat and routine patient samples.

“The DxA 5000 has removed many of the manual steps and is easy to use. You set the system up, you start it, and you can forget it,” Ram Doolman, PhD, director of the Automated Mega Laboratory at Sheba Medical Center (Tel Hashomer, Israel), site of the first DxA 5000 installation, said in a press release from Beckman Coulter. “Besides improving turnaround time by 25 percent, we have also managed to improve the usage of space. We went from two lines to one, which helped us free up half of our lab so we can now include microbiology, biochemistry, and hematology all in one lab, together.”

The DxA 5000 launched in Europe earlier this year.