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

MedTest
14 Sept 2016
Alex Waite
Editorial Assistant

Product news

Mindray has 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 walkaway 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.”

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HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.Robotic InstrumentsRobotic instruments can be used for high-throughput automation of many lab processes. Such processes use instruments for assays like cell based assays and ELISA, for sample preparation like shakers, centrifuges and incubators, and for analysis such as sequencing and western blot analyzers. Useful features of robotic instruments include speed, reproducibility, barcode readers, software and automation.Robotic WorkstationsRobotic workstations are automated platforms enabling the user to perform high-throughput, multi-application processes, from sample preparation tasks such as PCR set-up, DNA purification and NGS library preparation, to integrated sample prep and analysis workstations. Automation makes processes consistent, fast, precise and fully walk-away. Find the best robotic workstations in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Hematology SolutionsHematology solutions involve diagnostic tests and equipment used to analyze blood samples and diagnose blood disorders such as anemia, leukemia, and hemophilia. These tools include automated full blood count analyzers, reagents, and digital morphology systems. Explore hematology solutions in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.

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