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Libre 2 Sensor users: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. Libre 2 Plus Sensor users: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. Libre 3 Sensor users: The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. Libre 3 Plus Sensor users: The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use. The subject FSL3 System consists of a sensor (the FreeStyle Libre 3 Sensor (FSL3 Sensor) or FreeStyle Libre 3 Plus Sensor (FSL3 Plus Sensor)) and a primary display device (the FreeStyle Libre 3 Reader (FSL3 Reader) or the FreeStyle Libre App (FSL App) [iOS and Android] downloaded to a compatible phone). The FSL3 Reader and the FSL App do not interact with each other. The subject FSL2 System consists of a sensor (the FreeStyle Libre 2 Sensor (FSL2 Sensor) or FreeStyle Libre 2 Plus Sensor (FSL2 Plus Sensor)) and a primary display device (the FreeStyle Libre 2 Reader (FSL2 Reader) or the FSL App (iOS and Android) downloaded to a compatible phone). The FSL2 Reader and FSL App do not interact with each other. Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the sensor, continues to serve as a primary display device for the glucose data and alarms.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use. The FSL3 System consists of the FreeStyle Libre 3 Sensor and either the FreeStyle Libre 3 Reader or the FreeStyle Libre 3 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL3 Reader and FSL3 App do not interact with each other. The FSL2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL2 Reader and FSL2 App do not interact with each other. Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 2 Flash Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL2 System' and FreeStyle Libre 3 Continuous Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL3 System' are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The Systems also provide configurable alarms designed to warn the user of Low Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by the Systems require a prescription and are intended for home use. The FreeStyle Libre 2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The FreeStyle Libre 2 and FreeStyle Libre 3 are integrated continuous glucose monitoring (iCGM) Systems designed to be used alone or in conjunction with digitally connected devices. The FreeStyle Libre 2 System consists of a Sensor and either a Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of a Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both Systems can communicate glucose data and other information wirelessly and securely to and from these digitally connected devices as described below: - Wireless communication from the FreeStyle Libre 2 Sensor or FreeStyle Libre 3 Sensor directly to an interoperable receiver device, which connects with the Sensor using the near field communication (NFC) and Bluetooth Low Energy wireless interfaces provided by the Sensor - The FreeStyle Libre 2 App or FreeStyle Libre 3 App communicates through the cloud to another software device, such as LibreView. Compared to the respective predicate devices, the proposed subject devices include an additional software component, the Libre Data Sharing API. The Libre Data Sharing API is a cloud-based application programming interface (API) that enables communication of glucose data including alarms through the cloud from the FreeStyle Libre 2 System or FreeStyle Libre 3 System to authorized client software on digitally connected devices. The data transmitted by the API to authorized client software can be used for specific and permitted use cases, including nonmedical device applications, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. Use of the Libre Data Sharing API and the CGM information it transmits is limited by the indications for use of the iCGM systems with which it is used. The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 or FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the connected iCGM system are not modified or manipulated by the Libre Data Sharing API through its transmission to the authorized client software. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms. The current components of the FreeStyle Libre 2 and FreeStyle Libre 3 Systems (sensor/applicator and primary display devices) have not been modified as a result of the added the Libre Data Sharing API.

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running iOS operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running on Android operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day).

The FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 App -Android (herein referred to as the 'FreeStyle Libre 2 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends, and real time alarms capability to aid in the management of diabetes. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits yia Bluetooth Low Energy (BLE), a BLE enabled display device (Reader), and an Android or iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the Sensor via Reader or App provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 App (herein referred to as the 'FreeStyle Libre 2 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The System requires a prescription and is intended for home use. The System consists of the following components: a sensor which transmits via Bluetooth Low Energy (BLE), a BLE enabled display device (Reader), and an iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the sensor via Reader or App provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

The FreeStyle Libre 2 Flash Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 2 System or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The FreeStyle Libre 2 System consists of two primary components: a sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User-initiated RFID scanning provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may use the sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alerts and alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader's built-in meter as components of the Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or screening of diabetes. The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared.

The FreeStyle Precision Neo Blood Glucose Test Strips are used for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Blood Glucose Test Strips, in conjunction with the FreeStyle Libre Reader's built-in meter, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions through electrical mediation. The FreeStyle Precision Neo Blood Glucose Test Strips are compatible with the FreeStyle Precision Neo Blood Glucose Meter (cleared under k140371) or the FreeStyle Libre Reader's built-in meter.