Beckman Coulter gets DxA 5000 approvals

By staff writers

May 3, 2019 -- Beckman Coulter announced that its DxA 5000 lab automation system has received regulatory approvals in Europe and China.

DxA 5000 received the CE Mark in Europe and approval by the China Food and Drug Administration (CFDA). The system is designed to support clinical lab automation by providing a more efficient method for handling lab samples, reducing the number of manual processing steps to improve laboratory efficiency and support patient care.

For example, specimen centrifugation is a time-consuming preanalytical activity, according to research studies. DxA 5000 uses a universal centrifugation protocol that reduces preanalytical processing times by up to 73% for connected analyzers across multiple disciplines, the company said.

DxA 5000 also uses what Beckman Coulter calls "intelligent routing" to bring patient-centric workflow to the lab. The technology understands tests that are ordered, sample volume available, and real-time analyzer capacity and calculates the quickest route for both stat and routine patient samples.

DxA 5000 screens each patient sample at multiple points to help clinical labs reduce the risk of errors. The system takes three seconds to detect patient tube parameters such as volume, sample identification, tube type, cap color, orders pending, and tube weight. DxA 5000 also checks for sample volume at precentrifugation, postcentrifugation, and prior to sample storage phases; this ensures sufficient volume is available for the tests ordered.

Such quality assessments reduce the likelihood of erroneous results and can help accelerate the time to results by alerting lab staff when a new patient sample is needed.

Beckman Coulter has received orders for 20 DxA 5000 systems in countries where the product has been approved. It is pending 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is not yet available in the U.S.

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Last Updated np 5/3/2019 9:26:36 AM

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