Hematology analyzer cleared for use in US
Photo by William Weinert
The US Food and Drug Administration has granted 510(k) clearance for the BC-5390 Hematology Analyzer.
The product is designed to meet the testing needs of mid-volume hematology laboratories but offers 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 product’s built-in autoloader has a 40-sample capacity, but it processes up to 60 samples per hour and stores up to 100,000 results with histograms.
The BC-5390 Hematology Analyzer’s barcode reader and optional laboratory information system connectivity enables seamless sample data transmission.
And nearly all scheduled maintenance procedures are automated by touch buttons.
The BC-5390 Hematology Analyzer is manufactured by Mindray, and MedTest will be the primary distributor of the analyzer in the US.
“We are excited to launch the BC-5390 Hematology Analyzer into the United States laboratory market,” said Caroline Li, general manager of Mindray IVD North America.
“The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.” 