Nova StatStrip Glucose Analyzer Receives FDA Clearance for Neonatal Testing

Posted January 10th, 2012.

Nova’s new StatStrip™ Glucose Monitor has received clearance from the U.S. Food and Drug Administration for use in neonatal testing. Severe hematocrit abnormalities are routinely found in neonates. Other glucose monitors may report an error if the hematocrit value is abnormal, StatStrip is the only glucose monitor that measures hematocrit on the strip, automatically correcting glucose values for abnormal hematocrit values. In addition, its small 1.2 microliter sample volume is attractive for the NICU environment where blood conservation is essential.

Introduced in May 2006, StatStrip is rapidly becoming the gold standard in hospital glucose testing. Incorporating a patented new Multi-Well™ strip technology, StatStrip elevates bedside glucose monitoring to a level of speed, accuracy, quality, and patient safety on a par with central laboratory testing. In addition to hematocrit, StatStrip measures and corrects 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 6-second analysis time, color touch screen operation, and simple operating steps make bedside glucose testing fast and easy for point of care staff. Unlike competitive glucose analyzers, StatStrip requires no calibration codes thereby eliminating an operator step and preventing a potential input error.