Blood Glucose Meter Receives FDA Clearance for Critically Ill Hospital Patients
The FDA has cleared the Nova StatStrip Glucose Hospital Meter System to become the first blood glucose monitoring system for use in critically ill patients who have been hospitalized.
The FDA has cleared Nova Biomedical’s Nova StatStrip Glucose Hospital Meter System to become the first blood glucose monitoring system for use in critically ill patients who have been hospitalized.
The FDA originally approved the blood glucose meter in April 2006 to aid in monitoring the effectiveness of a diabetes control program in hospitals, but not for use in critically ill patients. Subsequently, Nova Biomedical submitted a new premarket submission to the FDA seeking approval for that indication.
After reviewing the company’s submission, the FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results. In addition to granting the new indication, the FDA granted it a waiver under Clinical Laboratory Improvement Amendments (CLIA), which will 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 (an) 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, 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.”
Blood glucose meters are used to manage many hospital patients, including those who require insulin to manage blood sugar. The FDA cleared the Nova StatStrip Glucose Hospital Meter System for indications that include using arterial or venous whole blood from patients in all areas of a hospital with various conditions, such as trauma, cancer, sepsis, and infection; cardiac, kidney, neurologic, obstetric, gynecologic, gastroenterologic, endocrine, and lung issues; and recovery from general or cardiothoracic surgery.
Data supporting the new indications encompassed a study of more than 1650 patients treated in various hospital departments that showed agreement in blood glucose results compared with a laboratory glucose analyzer.