The FDA today has extended the indication of the Nova StatStrip glucose hospital meter system to critically ill patients within hospitals; this is the first device cleared for this indication.
“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,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Devices at the FDA’s Center for Devices and Radiological Health, said in a press release. “It is important for manufacturers of glucose meters used in hospitals to design and test their devices for use in all hospitalized patients.”
In its announcement, the FDA reported finding the Nova StatStrip system (Nova Biomedical) “simple to use” and with a “low risk for false results.” With this indication, the system is exempt from additional complex tests required by the Clinical Laboratory Improvement Amendments, tests that would be required of any other system used in critically ill patients. That exemption allows health care practitioners to perform the monitoring of a patient’s glucose at the point-of-care rather than running the results through a laboratory, according to the release.
The Nova StatStrip glucose hospital meter system was originally cleared in 2006 for hospital use to monitor control of diabetes, but not for patients with critical illnesses.
Since that time, the FDA considered data from a study of more than 1,650 patients whose medical situations varied by condition, medication and hospital department.
“Results showed agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all patients types tested,” according to the release from the FDA.
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FDA clears glucose monitoring system for use in hospital critical care units