Beckman Coulter Diagnostics on Monday launched the DxI 9000 Access Immunoassay Analyzer, making it available in most countries worldwide.
The analyzer is designed to address demands for speed, reliability, reproducibility, quality, and menu expansion, the firm said.
The system has U.S. Food and Drug Administration (FDA) clearance and the CE Mark under the In Vitro Diagnostic Regulation (IVDR), a company spokesperson said in an email, adding that Beckman Coulter Diagnostics has also received approvals in countries in the Asia Pacific (APAC); Eastern Europe, the Middle East, and Africa (EEMEA); and Latin America regions.
“With the DxI 9000, Beckman Coulter has successfully produced a platform that addresses today’s laboratories needs for speed, accuracy, and reliability,” Dr. Ray Divilley, chief medical officer, Mayo University Hospital, Ireland, said in a statement. “Based on our use and evaluation of the system in our lab, we were able to get actionable results back quicker to doctors and ultimately patients as they consider treatment options.”
The analyzer can run up to 215 tests per hour per square meter. It consists of a ZeroDaily Maintenance feature that increases its uptime performance, Beckman Coulter said. Beta users attest to ZeroDaily Maintenance redefining their workday with no daily maintenance requirements, thereby reducing annual maintenance routines by up to 96%, the firm added.
The analyzer’s PrecisionVision feature consists of automated safeguards include tube identification, cap detection, tip check, sample aspiration and delivery, residual wash volume, and substrate volume. Each check reduces the risk of reporting flawed data and increases system reliability and reproducibility, the firm said.
Beckman Coulter added that its remote service and diagnostics solution, DxS IntelliServe, connects with DxI 9000 Analyzers to monitor data and error trends, enabling timely, proactive system service when needed.
The analyzer is available with the firm’s Access NT-proBNP assay, which measures concentrations of N-terminal pro B-type natriuretic peptide that originate in a person’s heart. High levels of natriuretic peptides can indicate heart failure. Access NT-proBNP provides rapid results in less than 11 minutes.
