Nova Biomedical’s StatStrip Xpress Glucose Meter Receives FDA CLIA Waived Designation

Posted February 12th, 2012.

WALTHAM, Mass. – Nova Biomedical’s StatStrip® Xpress™ glucose monitor has been granted CLIA-waived status from the U.S. Food and Drug Administration. StatStrip Xpress is Nova’s non-connectivity companion meter to the CLIA-waived StatStrip Hospital Glucose Meter. StatStrip Xpress can now be operated under a certificate of waiver in point-of-care settings such as ambulances and remote non-hospital locations that do not require the network capabilities of the StatStrip Hospital Glucose Meter.

Introduced in May 2006, StatStrip has rapidly become the standard in accurate hospital glucose testing, most recently being validated by over 34 peer-reviewed studies showing superior accuracy and interference-free results. 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. StatStrip Multi-Well test strips are the only test strips that measure and eliminate glucose errors due to varying hematocrit levels. StatStrip also eliminates interference due to maltose, galactose, xylose, oxygen, acetaminophen, uric acid, and ascorbic acid (Vitamin C).

Both the StatStrip Hospital Glucose Monitor and StatStrip Xpress meters feature 6-second analysis time and simple operating steps making bedside glucose testing fast and easy for point of care staff. Their 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 source of input errors.

About Nova Biomedical
Nova Biomedical, incorporated in 1976, is a world leader in the development and manufacture of state-of-the-art whole blood chemistry analyzers. The Nova product line ranges from small single-test meters for glucose self-testing and hospital-based point of care testing to full critical-care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova products are used by small, medium, and large hospitals worldwide to improve patient outcomes and reduce the cost of care.

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For further information, please contact:
Rick Rollins, Nova Biomedical, 200 Prospect Street, Waltham, MA 02454, USA
Tel: 781-647-3700 x579 / Fax: 781-894-5915 / Email: rrollins@novabio.com