Signos Glucose Monitoring System

The Signos Glucose Monitoring System is a mobile device application that pairs via Bluetooth with an over-the-counter continuous glucose monitor (iCGM) to display and trend glucose readings every 15 minutes. Intended for users 18 years and older not on insulin, it helps detect normal and abnormal glucose levels and assists users in understanding how diet and exercise impact glucose levels, with a display range of 70-250 mg/dL.

Both the subject device and predicate use the same underlying scientific technology, materials, and mechanism of operation—a mobile application displaying interstitial fluid glucose data via an iCGM sensor using glucose oxidase chemistry. Key characteristics are identical: Android/iOS host hardware, 70-250 mg/dL display range, 15-minute update intervals, no sensor calibration with the application, no alerts/alarms, and over-the-counter home use. The key difference is the subject device is an application interoperable with the iCGM, while the predicate includes the iCGM itself.

Not stated in this summary.

The Signos application is substantially equivalent because it performs the same fundamental function as the predicate—displaying and trending glucose data from the same iCGM sensor to help users understand glycemic control through lifestyle modification. Although the subject device is software-only (interoperable with the iCGM) whereas the predicate bundled the iCGM, both share identical display characteristics, update intervals, intended population, use setting, and regulatory classification. Software verification testing confirmed the application displays data identically to what the sensor transmits, cybersecurity testing showed acceptable risk levels, and human factors testing demonstrated no unacceptable usability risks, establishing functional and safety equivalence to the predicate.