News | March 03, 2008

Point-of-Care Blood Glucose Monitoring System Gets FDA-Waived Status

March 3, 2008 - Nova Biomedical said today its StatStrip point-of-care blood glucose monitoring system has received FDA CLIA-waived status so it can be used in point-of-care settings to perform testing under a CLIA certificate of waiver.

Incorporating Multi-Well strip technology, the StatStrip blood glucose monitoring system reportedly offers a new level of analytical performance that approaches the quality of central laboratory testing. StatStrip measures and corrects hematocrit interference as well as interferences from acetaminophen (Tylenol), uric acid, ascorbic acid (Vitamin C), maltose, galactose, xylose, and lactose. StatStrip also eliminates oxygen interference to provide accurate glucose results regardless of the sample’s oxygen status.

StatStrip’s six-second analysis time, color touch screen operation, and simple operating steps make bedside glucose testing fast and easy for point-of-care staff. Its small 1.2 microliter sample size results in easy sample acquisition and minimal pain for the patient. Unlike competitive glucose analyzers, StatStrip requires no calibration codes thereby eliminating an operator step and preventing a potential input error, the company says.

NovaNet software provides management and control of point-of-care testing, allows the StatStrip system to be customized to the needs of each testing location.

For more information: www.novabiomedical.com

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