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The US Food and Drug Administration has granted 510(k) clearance for the GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.
The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to quantify red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid collected from adult and pediatric patients.
Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte system.
The GloCyte system is designed to provide accurate cell counts at clinically relevant low levels to assist the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system.
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin, president and CEO of Advanced Instruments, Inc., makers of the GloCyte system.
“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.”
The GloCyte system includes the GloCyte instrument, computer (hardware and software), vacuum station, sample preparation tray, barcode reader, pipettes (10 and 30 μL), test cartridge, TNC and RBC reagents, and Low and High Level Controls.
The test method uses 1 of 2 reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti-human RBC antibody in buffer with stabilizers) and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.
The GloCyte system requires 30 μL of sample per test, and it uses disposable test cartridges to ensure no sample carryover. The system also includes Levey-Jennings charts and an audit table.
Advanced Instruments expects to begin shipping the GloCyte system in September. For more information about the system, visit aicompanies.com/glocyte. 
The US Food and Drug Administration has granted 510(k) clearance for the GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.
The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to quantify red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid collected from adult and pediatric patients.
Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte system.
The GloCyte system is designed to provide accurate cell counts at clinically relevant low levels to assist the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system.
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin, president and CEO of Advanced Instruments, Inc., makers of the GloCyte system.
“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.”
The GloCyte system includes the GloCyte instrument, computer (hardware and software), vacuum station, sample preparation tray, barcode reader, pipettes (10 and 30 μL), test cartridge, TNC and RBC reagents, and Low and High Level Controls.
The test method uses 1 of 2 reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti-human RBC antibody in buffer with stabilizers) and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.
The GloCyte system requires 30 μL of sample per test, and it uses disposable test cartridges to ensure no sample carryover. The system also includes Levey-Jennings charts and an audit table.
Advanced Instruments expects to begin shipping the GloCyte system in September. For more information about the system, visit aicompanies.com/glocyte.
The US Food and Drug Administration has granted 510(k) clearance for the GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.
The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to quantify red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid collected from adult and pediatric patients.
Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte system.
The GloCyte system is designed to provide accurate cell counts at clinically relevant low levels to assist the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system.
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin, president and CEO of Advanced Instruments, Inc., makers of the GloCyte system.
“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.”
The GloCyte system includes the GloCyte instrument, computer (hardware and software), vacuum station, sample preparation tray, barcode reader, pipettes (10 and 30 μL), test cartridge, TNC and RBC reagents, and Low and High Level Controls.
The test method uses 1 of 2 reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti-human RBC antibody in buffer with stabilizers) and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.
The GloCyte system requires 30 μL of sample per test, and it uses disposable test cartridges to ensure no sample carryover. The system also includes Levey-Jennings charts and an audit table.
Advanced Instruments expects to begin shipping the GloCyte system in September. For more information about the system, visit aicompanies.com/glocyte.