FreeStyle Libre 3 Continuous Glucose Monitoring System

K212132 · Abbott Diabetes Care, Inc. · QLG · May 26, 2022 · Clinical Chemistry

Device Facts

• Record ID: K212132
• Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: QLG · Clinical Chemistry
• Decision Date: May 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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.

Device Story

Integrated continuous glucose monitoring (iCGM) system; measures interstitial fluid glucose via subcutaneous sensor; uses glucose oxidase electrochemical reaction; converts current to glucose values. Sensor transmits data via Bluetooth Low Energy (BLE) to FreeStyle Libre 3 App on iOS smartphone. Provides real-time glucose measurements, trends, and alarms (Low/High/Signal Loss). Used in home setting by patients; supports therapy decisions. System autonomously communicates with digitally connected devices. Benefits include continuous monitoring without fingersticks, trend tracking, and automated alerts for glycemic management.

Clinical Evidence

Clinical evidence includes three studies (n=385 total) evaluating precision and accuracy. Study 3 (n=100) served as a confirmatory study for design modifications. Primary endpoints included MARD and concurrence rates against YSI laboratory reference (adults/pediatric 6-17) or SMBG (pediatric 4-5). Adult MARD was 9.8% (70-180 mg/dL range); pediatric MARD was 10.1% (70-180 mg/dL range). Alarm performance, sensor stability, and glucose capture rates were validated over 14-day wear.

Technological Characteristics

Amperometric electrochemical sensor using glucose oxidase; silver oxide battery; 14-day wear life; factory calibrated. Connectivity: BLE for data streaming, NFC for sensor activation. Sterilization: Electron beam (ISO 11137-1/2). Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, CISPR 11, AAMI TIR69, ANSI C63.27. Biocompatibility: ISO 10993-1.

Indications for Use

Indicated for management of diabetes in persons age 4 and older. Contraindicated for use with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Not for use in pregnant individuals, those on dialysis, or the critically ill.

Regulatory Classification

Identification

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) Robust clinical data demonstrating the accuracy of the device in the intended use population. (ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order ( *e.g.,* an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device. (iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period. (v) Clinical study results in the adult population must meet the following performance requirements: (A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent. (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent. (C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent. (D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent. (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent. (H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL. (I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL. (J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements. (K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements. (vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate. (vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use. (2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data. (3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section. (4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications. (5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period. (6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy. (7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites ( *e.g.,* abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL. (ii) A description of the accuracy of positive and negative rate of change data. (iii) A description of the frequency and duration of gaps in sensor data. (iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable. (v) A description of the observed duration of iCGM life for the device.

Predicate Devices

• FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 26, 2022

Abbott Diabetes Care Inc. Naveen Thuramalla Divisional Vice President, Regulatory Affairs 1360 South Loop Road Alameda, California 94502

Re: K212132

Trade/Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QLG Dated: April 8, 2022 Received: April 11, 2022

Dear Naveen Thuramalla:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicological Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### Device Name

Freetyle Libre 3 Continuous Glucose Monitoring System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable):

| <span style="font-family: DejaVu Sans, sans-serif">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a teal-colored abstract shape on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K212132

### Submitter

Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502

Contact: Naveen Thuramalla Title: Divisional Vice President, Regulatory Affairs Phone: [phone] Fax: [phone]

Date Prepared: May 16, 2022

#### Device Names and Classification

| Name of Device: | FreeStyle Libre 3 Continuous Glucose Monitoring System |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory<br>Calibrated, Not for use with automated insulin delivery systems |
| Regulatory Section: | 21 CFR 862.1355 |
| Classification: | Class II |
| Product Code(s): | QLG |
| Review Panel: | Clinical Chemistry |

### Predicate Device

- Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761)
The predicate device has not been subject to a recall

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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. On the left is a blue, stylized letter 'A'. To the right of the logo are the words "Abbott" in bold, black letters, with the words "Diabetes Care" underneath in a smaller, non-bold font. The logo is simple and professional, and the text is clear and easy to read.

## Indications for Use

### Indications for Use

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.

#### Contraindication

- Automated Insulin Dosing: The System must not be used with automated insulin dosing ● (AID) systems, including closed loop and insulin suspend systems.
- . MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and mav impact proper function of the device which could cause incorrect readings.

#### Device Description

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.

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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue, stylized letter "a" on the left, followed by the words "Abbott" in bold, black letters on the top line, and "Diabetes Care" in smaller, black letters on the bottom line. The logo is simple and modern, and the colors are clean and professional.

FreeStyle Libre 3 Sensor

- . The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided through a Sensor Applicator (which includes an electron beam sterilized sub-component) which is used to apply the Sensor to the back of the user's arm. The Sensor continuously measures glucose concentration in interstitial fluid and has a 14day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 3 App (iOS)

- The FreeStyle Libre 3 App design, functionality and user interface is based on the ● FreeStyle Libre 2 iOS App of the predicate device. When downloaded to a compatible iPhone, the FreeStyle Libre 3 App uses Near Field Communication to start new Sensors and BLE communication to display glucose data and issue alarms based on the measurements calculated by the Sensor. As a mobile application, the FreeStyle Libre 3 App allows connectivity with cloud-based applications. The FreeStyle Libre 3 App is distributed using the Apple App Store and a list of compatible devices is accessible in the App via the Help feature or product website.
### Substantial Equivalence

#### A. Predicate Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

#### Predicate 510(k) Number(s) B.

### K201761

#### C. Comparison with Predicate

The similarities and differences between the subject and the predicate device are highlighted in the tables below.

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Image /page/6/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the words "Abbott" in bold black letters on the top line and "Diabetes Care" in smaller black letters on the bottom line. The logo is simple and modern, and the use of blue and black gives it a professional look.

| Similarities | | |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device: FreeStyle Libre 3<br>Continuous Glucose Monitoring System | Predicate Device: FreeStyle Libre 2<br>Flash Glucose Monitoring System<br>(with FreeStyle Libre 2 App)<br>(K201761) |
| Intended Use | The System is intended to monitor<br>interstitial fluid glucose concentrations<br>and communicate with digitally<br>connected devices for the purpose of<br>managing a disease or condition related<br>to glycemic control. | Same |
| Device Type | Integrated CGM | Same |
| Principle of<br>Operation | Amperometric measurement of current<br>proportional to glucose concentration in<br>interstitial fluid via glucose oxidase<br>chemical reaction | Same |
| Test Range | 40 to 400 mg/dL | Same |
| Clinical Application | Management of diabetes mellitus | Same |
| Intended Use<br>Population | Persons with diabetes age 4 and older | Same |
| Clinical Setting/Sites<br>of Use | Home use | Same |
| Data Displayed | Current glucose value, current glucose<br>trend, graph with recent glucose<br>history, user entered events | Same |
| Method of Sensor<br>Activation | Near Field Communication (NFC) | Same |
| Wireless<br>Communication<br>Protocol | NFC: 13.56 MHz RFID<br>Bluetooth Low Energy (BLE) | Same |
| Sensor Glucose<br>Algorithm | ADC Glucose Algorithm established<br>for the predicate device | Same |
| Glucose Reading<br>Update Interval | Every 1 minute | Same |
| Glucose History | Graph and other reports can be used to<br>view logged data | Same |
| Glucose Trend<br>Arrows | ↑, > +2 mg/dL/min<br>↗, +1 to +2 mg/dL/min<br>→, -1 to +1 mg/dL/min<br>↘, -2 to -1 mg/dL/min<br>↓, < -2 mg/dL/min | Same |
| Situations where<br>Fingerstick Test is<br>Required to Confirm<br>Sensor Reading<br>(Adjunctive Use) | • The user's symptoms do not match the<br>glucose values displayed by the<br>device.<br>• The device does not show a glucose<br>value<br>• During the first 12 hours of wear<br>during which the check blood glucose | Same |
| Similarities | | |
| Device | Subject Device: FreeStyle Libre 3<br>Continuous Glucose Monitoring<br>System | Predicate Device: FreeStyle Libre 2<br>Flash Glucose Monitoring System<br>(with FreeStyle Libre 2 App)<br>(K201761) |
| Mandatory Alarms | Glucose Alarms: Urgent Low Glucose<br><br>System Alarms: Replace Sensor,<br>Sensor Ended, Check Sensor, App<br>Stopped<br><br>These alarms are mandatory (set to<br>'On') and cannot be turned off or<br>modified by the user. It will always<br>sound regardless of the phone sound<br>and vibe or Do Not Disturb settings. | Same<br><br>Note: The Check Sensor condition is<br>checked during the NFC scan, and<br>detects when a Sensor has not been<br>activated. |
| Optional Alarms | Glucose Alarms: Low Glucose Alarm,<br>High Glucose Alarm;<br><br>System Alarm: Signal Loss Alarm | Same |
| Blood Glucose Meter<br>(BGM) | While using the App, user must have<br>access to a blood glucose monitoring<br>system as the App does not provide<br>one. | Same |
| Method of<br>Communication and<br>Connectivity with<br>Cloud-based<br>Applications for the<br>App | App can communicate wirelessly to<br>LibreView. Through LibreView, can<br>communicate to LibreLinkUp App | Same |
| Compatibility with<br>Connected Devices | Compatible with digitally connected<br>devices where the user manually<br>controls actions for therapy decisions | Same |
| Compatible<br>Operating Systems<br>and Hardware<br>Platform for the App | Compatible with Apple iOS | Same |
| Sensor Calibration | Factory Calibrated | Same |
| Compatible Sensor<br>Warmup time | 1 hour | Same |
| Compatible Sensor<br>Life | Up to 14 days (automatic Sensor shut<br>off) | Same |
| Differences | | |
| Device | Subject Device: FreeStyle Libre 3<br>Continuous Glucose Monitoring System | Predicate Device: FreeStyle Libre 2<br>Flash Glucose Monitoring System (with<br>FreeStyle Libre 2 App) (K201761) |
| Indications for<br>Use | The FreeStyle Libre 3 Continuous<br>Glucose Monitoring System is a real time<br>continuous glucose monitoring (CGM)<br>device with alarms capability indicated for<br>the management of diabetes in persons<br>age 4 and older. It is intended to replace<br>blood glucose testing for diabetes<br>treatment decisions, unless otherwise<br>indicated.<br><br>The System also detects trends and tracks<br>patterns and aids in the detection of<br>episodes of hyperglycemia and<br>hypoglycemia, facilitating both acute and<br>long-term therapy adjustments.<br>Interpretation of the System readings<br>should be based on the glucose trends and<br>several sequential readings over time.<br><br>The System is also intended to<br>autonomously communicate with digitally<br>connected devices. The System can be<br>used alone or in conjunction with these<br>digitally connected devices where the user<br>manually controls actions for therapy<br>decisions. | The FreeStyle Libre 2 Flash Glucose<br>Monitoring System is a continuous<br>glucose monitoring (CGM) device with<br>real time alarms capability indicated for<br>the management of diabetes in persons<br>age 4 and older. It is intended to replace<br>blood glucose testing for diabetes<br>treatment decisions, unless otherwise<br>indicated.<br><br>The System also detects trends and tracks<br>patterns and aids in the detection of<br>episodes of hyperglycemia and<br>hypoglycemia, facilitating both acute and<br>long-term therapy adjustments.<br>Interpretation of the System readings<br>should be based on the glucose trends and<br>several sequential readings over time.<br><br>The System is also intended to<br>autonomously communicate with digitally<br>connected devices. The System can be<br>used alone or in conjunction with these<br>digitally connected devices where the user<br>manually controls actions for therapy<br>decisions. |
| System<br>Components | On-body Sensor<br>(No Sensor Applicator assembly required<br>by user prior to applying the Sensor)<br><br>FreeStyle Libre 3 App | On-body Sensor<br>(User assembles Sensor Applicator and<br>Sensor Container prior to applying the<br>Sensor)<br><br>FreeStyle Libre 2 App or FreeStyle Libre<br>2 Reader…