Beckman Coulters AU5800 Chemistry Systems Receive FDA Clearance

Beckman Coulter has received US Food and Drug Administration (FDA) clearance for its AU5800 automated chemistry systems. The AU5800 systems can be used as stand-alone instruments, or as components of Beckman Coulters automated solutions.

The AU5800 series is capable of meeting the demands of high- and ultra-high-volume clinical laboratories. The series includes the AU5840 configuration which is the fastest AU analyzer ever designed. The AU5800 throughput performance ranges from 2,000 photometric chemistry tests per hour for the single module configuration (AU5810), to up to 9,800 photometric/electrolyte tests per hour with a dual ISE flow cell, four-unit configuration (AU5840).

The AU5800 series offers laboratories a clear upgrade path, allowing them to add components as their workflow demands increase. They can also be integrated with Beckman Coulters clinical information systems and immunoassay testing platforms to meet specific performance needs.

“AU5800 analyzers demonstrate innovation in design and a commitment to our continued investment in Beckman Coulter’s solutions for the lab,” said Tom Joyce, president, Beckman Coulter Diagnostics. “The series further bolsters the complete line of AU chemistry systems which work to increase efficiency through standardization and boost lab productivity, delivering critical patient health information and helping to reduce the cost of care.”

“Currently there are nearly 50 AU5800 systems in use in Japan and Europe,” said John Blackwood, vice president of Beckman Coulter Diagnostics Product Management. “With FDA clearance of the AU5800 series, we can now offer the tremendous reliability, scalability, standardization and performance capabilities needed to improve and enhance the operations of our customers in the U.S.”