Mindray™ & MedTest Announce FDA 510(k) Clearance for the BS-480 Chemistry Analyzer

Mindray™ and MedTest jointly announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray™ BS-480 Chemistry Analyzer. The Mindray™ BS-480 Analyzer meets the testing needs of mid-volume laboratories while offering state-of-the-art features commonly found on large volume analyzers.

The BS-480 Analyzer produces 400 photometric test results per hour, 240 ISE tests per hour with an overall throughput of 560 tests per hour. Advanced features of the BS-480 analyzer include numerous automatic processes such as Auto-Start-Up, QC, Rerun, Pre-Dilution, Post-Dilution, ISE Calibration, Probe Cleaning, Reagent Blank Checks and Probe Collision Recovery which provides the laboratory with smooth operational and enhanced workflow efficiencies.

Finn Li, Ph.D., General Manager, Mindray™ IVD North America, stated: "We are excited to launch the BS-480 analyzer into the United States laboratory market. Mindray™ enjoys satisfied customer experiences with this analyzer outside of the US and looks forward to adding US customers to our installed base. As Mindray™ has grown rapidly in global markets; the commercialization of the BS-480 further enhances our presence in the US in-vitro diagnostic market, enabling us to continue to introduce new and innovative products for the clinical laboratory in the future."

MedTest is the exclusive US distributor of the BS-480 Chemistry Analyzer including; manufacturing and distribution of reagents, calibrators and quality control products for the general chemistry and drugs of abuse testing markets. Hanjoon Ryu, MedTest’s CEO, stated: "Mid- and mid-high volume laboratories deserve a more integrated service provider who offers innovative instruments with proven quality reagents, superior customer support and recognized economic advantages. Partnered with the Mindray™ BS-200 Bench-Top Chemistry Analyzer, the BS-480 Analyzer enables MedTest to offer a unique testing solution for the Integrated Delivery Networks (IDNs) and Group Purchasing Organizations (GPOs) in the United States. Our solution will provide commutable testing results between the core and satellite laboratory. We are delighted to share this announcement with our strategic partner, Mindray™."