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The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

The Signos Glucose Monitoring System is a mobile device application that is paired, via Bluetooth®, with an over-the-counter interoperable continuous glucose monitor (iCGM). The application functions as a primary display for the iCGM by showing the user's glucose reading along with a historic trend every 15 minutes. The system is capable of backfilling missed data and supporting a grace period dictated by the iCGM. The system's various displays, text, graphs, suggestions, and notifications serve to clearly illustrate the user's past and present glucose readings and their trend direction to assist the user in maintaining a euglycemic state. The glucose display range is 70 mg/dL to 250 mg/dL. The Signos System is intended for users over the age of 18 not on insulin.

The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

The Lingo Glucose System (also referred to as 'System') is Abbott's latest biowearable evolution in health technology for glucose measurement. This system encourages users 18 years and older not on insulin, to understand how glucose impacts their body. The Lingo Glucose System includes the Lingo Glucose Biosensor and the Lingo App. Lingo Biosensor: The Lingo Glucose Biosensor hardware and technology is based on the FDA-cleared FreeStyle Libre 2 (FSL2) sensor (K222447). The Biosensor is a single use disposable on-body Biosensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated electronics. The Biosensor can be worn for up for 14 days and transmits data to the Lingo App via Bluetooth Low Energy (BLE). Similar to the predicate device, a disposable Biosensor insertion device, consisting of a Biosensor Applicator and Biosensor Pack is used to assemble and apply the Biosensor to the back of the user's upper arm. Lingo App (iOS): When downloaded on a compatible smartphone running on iOS, the Lingo App uses Near-Field Communication (NFC) to start a new Biosensor and uses BLE to receive glucose data from the Biosensor. The user can view real-time glucose value, trend arrow, and glucose graph on the app through a glucose range of 55-200 mg/dL. The Lingo App contains on-boarding materials with a self-selection questionnaire that a user must consent prior to using the device. The App does not provide any glucose or system alerts.

The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (CCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healtheare professional.

The Stelo Glucose Biosensor system (Stelo System) is an over-the-counter (OTC) interoperable continuous glucose monitoring (iCGM) system. The Stelo Glucose Biosensor system (Stelo System) is an interoperable connected device that measures and displays estimated glucose values for people who are not on insulin. The Stelo System consists of the following components: the Glucose Sensing Subsystem (GSS) and the Mobile Application Subsystem (MAS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS is an app that can be downloaded to a compatible smart device and that presents glucose readings and qlucose trend to the user every 15 minutes. As such, the most recent displayed glucose value might be up to 15 minutes old. Each sensor session lasts up to 15 days with an extended 12-hour grace period. The grace period allows additional time for the user to change the sensor at a convenient time. The proposed Stelo System is based on the same mode of operation and mechanism of reaction as the predicate G7 CGM System (K231081), which uses a wire type sensing mechanism that continuously measures interstitial fluid qlucose levels and a BLE enabled radio transmitter to wirelessly communicate CGM data to compatible display devices at regular 5-minute intervals. These data are also able to be reliably and securely transmitted to other digitally connected devices, excluding insulin pens and Automated Insulin Dosing (AID) systems. The Stelo System uses the same hardware design as the predicate G7 CGM System. The Stelo GSS firmware is designed to support a factory-calibrated only device (without calibration inputs), to extend the sensor wear duration from 10 to 15 days while maintaining the accuracy of the device, and to connect to authorized display devices only (i.e., Stelo MAS). The Stelo MAS includes a redesigned user interface (UI) tailored to the Stelo System's user population to simplify the use of the device. The UI includes an app onboarding specific to the Stelo MAS design and its intended use, the most recent glucose value and trend graph which are updated every 15 minutes, a narrowed glucose range display from 70 mg/dL, and an "Insights" feature providing the time in range percentage with suggestions to help users improve their time in range. The Ul does not provide any glucose or system alerts.