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Mindray and MedTest announce FDA 510(k) Clearance for the BA-800M Clinical Chemistry Analyzer

Jul 26, 2016 - press releases

(Mahwah, New Jersey & Canton, Michigan)  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 BA-800M Clinical Chemistry Analyzer.  The Mindray BA-800M Analyzer meets the testing needs of mid-high volume laboratories offering state-of-the-art features.

The BA-800M Chemistry Analyzer produces 800 photometric test results per hour with an overall throughput of 1200 tests per hour with ISE.  The Sample Delivery Module provides a sample capacity of 440 positions, providing large-volume laboratories hours of unmanned operational time.  The reagent consumption design of this analyzer minimizes reagent usage per test and reduces the reagent bottle dead volume insuring that the laboratory is efficiently utilizing the reagents and providing the lowest consumption cost per test.   Advanced features of the BA-800M Analyzer include continuous reagent loading, Reagent Bubble Detection, Water Quality Monitor, One-Key STAT Touch button, Probe Liquid Level Detection and Sample Probe Clot and Collision Recovery which provides the laboratory with smooth operational and enhanced workflow efficiencies. 

Caroline Li, General Manager of Mindray IVD North America, stated:  “As Mindray has grown rapidly in global markets, the commercialization of the BA-800M Clinical Chemistry Analyzer further enhances our growth and 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.  Mindray enjoys satisfied customer experiences with this analyzer outside of the US and looks forward to adding US customers to our installed base.”

MedTest is the exclusive US distributor of the BA-800M Clinical Chemistry Analyzer including manufacturing and distribution of reagents, calibrators and quality control products for the general chemistry and urine drugs of abuse screening markets.  Hanjoon Ryu, CEO of MedTest, stated: “The introduction of the BA-800M Analyzer is another example of our continuous focus on scalable solutions for the diagnostic laboratory in the United States.  Partnered with the bench-top BS-200 Chemistry Analyzer and the BS-480 Analyzer, the BA-800M Analyzer enables MedTest to offer a unique and scalable testing solution for the Integrated Delivery Networks (IDNs) and Group Purchasing Organizations (GPOs) in the United States.  Our solutions will provide commutable testing results across the large core laboratory and the smaller satellite laboratory.  We are delighted to share this announcement with our strategic partner, Mindray.”

About Mindray:  Mindray is a leading developer, manufacturer and marketer of medical devices worldwide. Mindray maintains the global headquarters in Shenzhen, China, the U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From the main manufacturing and engineering base in China, Mindray supplies through our worldwide distribution network a broad range of products across three primary business segments, namely patient monitoring and life support, in-vitro diagnostic, and medical imaging systems.

About MedTest:  MedTest is a diagnostics company that provides automated, fast, and cost effective blood and urine testing solutions for diabetes, cardiovascular disease, drugs of abuse, pain management and wellness testing.  In June 2013, MedTest acquired Pointe Scientific, a company that has been developing, manufacturing and distributing clinical diagnostic products including clinical chemistry reagents and instruments in the United States and internationally since 1981.  In the fall of 2014, MedTest acquired Clinitox Diagnostix, a company that manufactures and supports drug confirmatory testing via Liquid Chromatography/Mass Spectrometry (LC/MS).

For additional information:

MedTest Mindray
Debbie Whitehair, MT(ASCP)SC Caroline Li 
Vice President, Marketing General Manager of  Mindray IVD North America
484.748.1603 800.288.2121 Ext. 2152

PR-M1114-01   07/16