StatStrip Xpress Glucose Meters Receive FDA Clearance-Capillary Testing with Critically Ill Patients

StatStrip Glucose and StatStrip Xpress2 Glucose meters
StatStrip Glucose and StatStrip Xpress2 Glucose meters
WALTHAM, Mass. - Jan. 25, 2019 - PRLog -- Nova Biomedical is pleased to announce that the StatStrip Xpress® and StatStrip Xpress 2 glucose meters have been cleared by the U.S. Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K182552 and K182549, respectively)—joining the StatStrip Glucose Hospital Meter System, which received the same labeling in July of 2018 (K181043). StatStrip glucose meters are the only glucose meters that have earned this clearance, and all three meters can now be used with arterial, venous, or capillary specimens from all patients including those who are critically ill. The use of any other meter with critically ill patients is considered off label by the FDA and high complexity testing by the Centers for Medicare and Medicaid Services.

StatStrip glucose meters are also the only point-of-care (POC) meters cleared under the FDA's new Product Code PZI (Prescription Use Blood Glucose Meter for Near-Patient Testing) for glucose testing throughout all hospital and all professional healthcare settings. All other glucose meters are cleared only for self-monitoring of blood glucose by non-hospitalized people with diabetes (Product Code NBW).

StatStrip Xpress and StatStrip Xpress 2 are designed for hospitals or clinics that do not require the data connectivity capabilities of the StatStrip hospital meter. Both Xpress meters use the same accurate StatStrip glucose test strip and retain all of its analytical performance features.

Nova's patented glucose measurement technology is the primary reason for the clinically acceptable accuracy of StatStrip's capillary glucose results. It's the only glucose technology for POC testing that measures and corrects for abnormal hematocrit levels and has no clinically significant interferences, which can lead to the mismanagement of critically ill patients. Hospitals using other glucose meters cannot test critically ill patients with those meters regardless of specimen type (arterial, capillary, or venous); such use is considered off label.

In 2014, StatStrip became the only glucose meter to receive FDA clearance for arterial, venous, neonatal arterial, and neonatal heel stick use in all hospital and all professional healthcare settings, including with critically ill patients (K132121). This clearance was based upon a multicenter, four-year, prospective study conducted at five prestigious university medical centers. In that study, whole blood glucose measurements of 1,698 critically ill patients spanning 257 different medical conditions and over 8,000 medications were found to be equivalent to plasma glucose central laboratory IDMS traceable methods.

About Nova Biomedical

Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova's biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova's biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 16 critical cell culture tests with 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,200 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, France, Germany, Great Britain, Italy, Japan, Spain, Switzerland, and Taiwan.

Ron Newby
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