For Immediate Release
September 24, 2014
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.
Blood glucose monitoring systems, also called blood glucose meters, are handheld devices that measure the amount of sugar (glucose) in blood by analyzing a small drop of blood that is placed on a test strip. After inserting the test strip into the device, the system displays a glucose level reading. Blood glucose measurements are used in the management of many patients in the hospital, including patients requiring insulin to manage blood sugar, and in the assessment of blood glucose levels in newborn babies.
The Nova StatStrip Glucose Hospital Meter System is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients.
Users of BGMS with manufacturer instructions that do not provide for use with critically ill hospital patients would be subject to the high complexity testing requirements under the Clinical Laboratory Improvement Amendments (CLIA) if such systems were to be used in the critically ill hospital population. Those requirements include the validation of how well the BGMS worked in that patient population.
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 CLIA. This waived status will allow a broad variety of health care professionals, such as nurses and technicians, to perform the test at the point-of-care, such as at a patient’s 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.
“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 FDA’s Center for Devices and Radiological Health. “It is important for manufacturers of glucose meters used in hospitals to design and test their devices for use in all hospitalized patients.”
The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April of 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. The device manufacturer submitted a new premarket submission to the FDA seeking clearance of the device with this new indication.
Today’s clearance is for indications that include using arterial or venous whole blood from patients in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery.
Data supporting this 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. Results showed agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all patients types tested.
The Nova StatStrip Glucose Hospital Meter System is manufactured by Nova Biomedical in Waltham, Massachusetts.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.