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Mindray and MedTest announce FDA 510(k) Clearance for the BC-5390 Hematology Analyzer

Sep 14, 2016 - press releases

(Mahwah, New Jersey & Canton, Michigan)  Mindray announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray BC-5390 Auto Hematology Analyzer.  The Mindray BC-5390 Analyzer meets the testing needs of mid-volume hematology laboratories while offering state-of-the-art features commonly found on large volume analyzers.

The BC-5390 Hematology Analyzer provides a complete blood count with 21 parameters and a 5-part differential from a venous or capillary blood sample.  The built in autoloader with 40 sample capacity enhances operator walk-away time. Hemoglobin analysis is performed using cyanide-free reagents. The analyzer processes up to 60 samples per hour and stores up to 100,000 results with histograms. The barcode reader and optional LIS connectivity enables seamless sample data transmission.  Nearly all scheduled maintenance procedures are automated by touch buttons.  The intuitive software enhances workflow efficiency and offers the operator a pleasant user experience.” 

Caroline Li, General Manager of Mindray IVD North America, stated:  “We are excited to launch the BC-5390 Hematology 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.  The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.  This commercialization further enhances Mindray’s 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 a primary distributor of the BC-5390 Hematology Analyzer in the US and Canada. Hanjoon Ryu, CEO of MedTest, stated: “Partnered with the bench-top BS-200 Chemistry Analyzer, the BS-480 Chemistry Analyzer or the BA-800M Chemistry Analyzer, the addition of the BC-5390 Hematology Analyzer enables MedTest to offer a total testing solution that meets the requirements of both the hematology and chemistry laboratories. 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-M1115-01   09/16