The U.S. Food and Drug Administration has approved a new indication for a blood glucose monitoring system, extending its use to critically ill patients who have been hospitalized and making it the first system of its kind to be cleared for use in these types of patients.
The handheld Nova StatStrip Glucose Hospital Meter System from Nova Biomedical in Waltham, Mass., has the distinction of being the first FDA-approved device specifically indicated for use in all types of hospital patients. The device was originally cleared by the FDA in April 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use with critically ill patients. However, Nova Biomedical submitted a new premarket submission to the regulatory agency seeking clearance of the device with this new indication.
Data supporting the FDA clearance included a study of more than 1,650 patients with a range of medical conditions, taking various medications, and being treated in a variety of hospital departments, such as cardiac, emergency intensive care, and surgical, with results showing agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all patients types tested.
The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results, and granted with the clearance waived test system status under [Clinical Laboratory Improvement Amendments], the agency said. This waived status will allow a broad variety of healthcare professionals, such as nurses and technicians, to perform the test at the point-of-care, such as at a patients bedside, instead of requiring that the test be performed in a hospital lab (or other lab) that meets the CLIA requirements for high complexity testing.
The CLIA waiver will also allow hospital labs to safely provide blood glucose monitoring to their critically ill patients without having to meet the significant CLIA requirements for high complexity testing, according to the FDA.
This device provides an important public health resource for critically ill hospitalized patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading, said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Devices at the FDAs Center for Devices and Radiological Health, in a written statement. It is important for manufacturers of glucose meters used in hospitals to design and test their devices for use in all hospitalized patients.
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