Second Nova glucose meter cleared for ICU
The FDA cleared Nova Biomedical’s StatStrip Xpress Glucose Hospital Meter System for use throughout all hospital and all professional health care settings, including patients in the intensive care unit. StatStrip Glucose and StatStrip Xpress Glucose are now the only two hospital blood glucose meters to be cleared by the FDA for use with critically ill patients. Use of all other glucose meters with critically ill patients is considered off-label by the FDA and high-complexity testing under the Clinical Laboratory Improvement Amendments.
StatStrip Xpress Glucose uses the same test strip measurement technology as StatStrip Glucose, which was cleared in 2014 after a four-year study conducted at five university medical centers. The study included 1,698 critically ill patients with over 257 medical condition subcategories as designated by the World Health organization. More than 8,000 medications were investigated for potential interference with StatStrip Glucose measuring technology. StatStrip Glucose demonstrated excellent agreement compared with central laboratory reference methods and no clinical interferences were found.