FDA www.fda.gov has cleared the StatStrip Glucose Hospital Meter System manufactured by Nova Biomedical www.novabiomedical.com in Massachusetts to use with critically ill patients who have been hospitalized.
Because of the unacceptably high rate of adverse patient events linked to the point-of-care use of glucose meters within hospitals, FDA recognized the need for more accurate and better performance standards for point-of-care glucose testing in hospitals especially in intensive care settings.
The studies with a great deal of data supporting the clearance included more than 1,650 patients with a range of medical conditions, patients taking various medications, and patients being treated in a variety of hospital departments. Results showed agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all of the patient types tested.
Nova Biomedical’s StatStrip Glucose Hospital Meter System is a handheld device that measures the amount of glucose in blood by analyzing a small drop of blood placed on a test strip. After inserting the test strip into the device, the system displays a glucose level reading.
Nova Biomedical’s StatStrip Glucose Hospital Meter System was evaluated against several rigorous performance criteria, statistical analyses tools, and insulin dosing error risk assessment models used by medical professionals, standards organizations, and regulators.
As a result, StatStrip Glucose was cleared by FDA for the detection and management of dysglycemia throughout all professional healthcare settings including critical care and is also CLIA waived in all settings.
The system must include manufacturer instructions that states specifically for use with critically ill hospital patients. If these instructions are not given, then the system will be subject to high complexity testing requirements under the Clinical Laboratory Improvement Amendments (CLIA).