October 9, 2019 -- Beckman Coulter's DxA 5000 lab automation system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now available.
The company announced the FDA clearance and the system's availability in the U.S. on October 9, following a decision by the FDA on October 4. Beckman Coulter had showcased the DxA 5000 system, along with other workflow solutions for improving throughput in labs, at the American Association for Clinical Chemistry annual meeting in August and announced its approvals in Europe and China in May.
The DxA 5000 is being pitched as a system for labs of all sizes. According to the company, it reduces the number of manual steps required to process patient samples from 32 to four and intelligently routes specimens in accordance with capacity.