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FDA Clears Advanced Instruments’ Automated Cell Counter System

GloCyte requires only 30 microliters of sample per test.

Advanced Instruments Inc. announced today (21 July) that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.
 
The patented GloCyte System is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid (CSF) collected from adult and pediatric patients. CSF is collected when physicians rely on cell counts to assist the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system (CNS). Currently, low cell counts can present a challenge to standard methods. 
 
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin, President and CEO of Advanced Instruments. “We use a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts. We are very excited as this marks a major achievement in giving laboratories a new way to obtain reliable and timely CSF results.”


 
Additional benefits of the GloCyte System are that the test requires only 30 microliters of sample per test, it uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes built-in quality control of Levey-Jennings charts and an audit table. The company expects to begin GloCyte shipments in September of this year.

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