FreeStyle Libre 2 System, FreeStyle Libre 3 System

K223537 · Abbott Diabetes Care, Inc. · QLG · Feb 21, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223537
• Device Name: FreeStyle Libre 2 System, FreeStyle Libre 3 System
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: QLG · Clinical Chemistry
• Decision Date: Feb 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

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 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) systems; measure interstitial fluid glucose via amperometric sensor (glucose oxidase reaction). Sensor applies to back of arm; transmits data via NFC/BLE to primary display (Reader or smartphone app). Subject devices add Libre Data Sharing API; cloud-based interface enabling secure transmission of glucose data/alarms to authorized third-party client software. API does not control system or modify data. Used in home setting by patients for diabetes management; provides real-time glucose values, trends, and alarms. Enables integration with digitally connected devices for patient monitoring and therapy decisions. Benefits include continuous glucose visibility without fingersticks, facilitating acute/long-term therapy adjustments.

Clinical Evidence

No new clinical data provided. Analytical performance, precision, accuracy, and other supportive characteristics were established in previous clearances (K210943, K213996) and remain unaffected by the API addition. Verification and validation focused on software and cybersecurity performance.

Technological Characteristics

Cloud-based API for data transmission; utilizes a 'whitelist' access control mechanism. No modifications to sensors, transmitters, or user interfaces. Operates as a component of iCGM systems compliant with 21 CFR 862.1355. Cybersecurity controls implemented for secure data transmission.

Indications for Use

Indicated for management of diabetes in persons age 4 and older. Replaces blood glucose testing for treatment decisions. Detects trends/patterns and aids in detection of hyperglycemia and hypoglycemia. Contraindicated for use with automated insulin dosing (AID) systems; must be removed prior to MRI, CT, or diathermy.

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 (K210943)
• FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996, K212132)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K223537

B Applicant

Abbott Diabetes Care, Inc.

C Proprietary and Established Names

FreeStyle Libre 2 Flash Glucose Monitoring System, FreeStyle Libre 3 Continuous Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QLG | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitoring System | CH - Clinical Chemistry |
| NBW | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

The submission adds application programming interfaces (APIs) to the FreeStyle Libre 2 and FreeStyle Libre 3 iCGM systems to facilitate users sharing glucose data with authorized client software for specific and permitted use cases.

B Type of Test:

Quantitative, amperometric assay (Glucose Oxidase)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for Use:

The Indications for Use statement for the FreeStyle Libre 2 Flash Glucose Monitoring System previously included a statement regarding sensor compatibility. This statement has been removed in the current submission. This modification does not change the cleared indications for use or intended use of the device system. Information on sensor compatibility can be found in device labeling.

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 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.

### C Contraindications

The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

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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 may impact proper function of the device which could cause incorrect readings.

## D Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

The following special conditions for use statements apply to the Libre Data Sharing API:

- 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 following special conditions for use statements apply to the FreeStyle Libre 2 (FSL2) device:

- Taking ascorbic Acid (Vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Inaccurate sensor readings due to ascorbic acid interference may be clinical significant and result in harm if relied on to make treatment decisions. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event.
- Do not use this system if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.
- Do not ignore symptoms that may be due to low or high blood glucose: if you are experiencing symptoms that are not consistent with the glucose readings, consult your health care professional.
- Do not use the System in people less than 4 years of age.
- Use your blood glucose meter to make diabetes treatment decisions when you see the "check blood glucose" symbol during the first 12 hours of wearing a Sensor. In addition, use your blood glucose meter to make diabetes treatment decisions, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number.
- Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full wear duration specified by your Sensor insert and help prevent it from falling off early.
- Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings. If you suspect that the temperature may exceed 82°F (e.g., an un-airconditioned home in the summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
- The Reader's built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
- The Reader's built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
- The Reader's built-in meter is for use by a single person. Use of the Reader's built-in meter on multiple patients may lead to transmission of Human Immunodeficiency Virus

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(HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

- Use of the Sensor with devices, apps, and software that are not listed (as compatible) may cause inaccurate glucose readings.
- If a Sensor breaks inside a user's body, call your health care professional.
- Alarms you receive do not include your glucose reading. You must scan the Sensor to get your real-time current glucose level as the Reader and App will not provide this information without a scan.
- For you to receive alarms, they must be on in your Reader. If you want to receive the App's optional alarms, make sure these are turned on. The Reader or phone should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive glucose alarms.
- To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
- The App will ask for phone permissions which are needed to receive alarms. Allow these permissions when requested.
- Check to make sure that you have the correct phone settings and permissions enabled. If your phone is not configured properly, you will not be able to use the App, so you will not receive alarms or be able to check your glucose.
- Do not force close the App (iOS). The App must be running in the background to receive alarms. If you force close the App you will not receive alarms. Re-open the App to ensure you will receive alarms.
- If you adjust the phone ringer volume (iPhone) or Media volume (Android) to silent or use the phone Do Not Disturb setting, keep 'Override Do Not Disturb' setting in the App ON for Low Glucose, High Glucose, and Signal Loss alarms to ensure you receive audible alarms.
- You should disconnect headphones or speakers from your phone when you are not using them as you may not hear audio for alarms. If using headphones, keep them in your ears.
- If you are using peripheral devices connected to your phone, such as wireless headphones or a smartwatch, you may receive alarms on only one device or peripheral, not all.
- Some operating system features may impact your ability to receive alarms. For example, if you use an iPhone and the iOS Screen Time feature, add FreeStyle Libre 2 to the list of Always Allowed apps to ensure that you receive alarms or if you use an Android Phone do not use the Android Digital Wellbeing app.
- Keep your phone well charged and turned on.
- If you are using FreeStyle Libre 2 App, you must have access to a blood glucose monitoring system as the App does not provide one.
- FreeStyle Libre 2 System is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.

The following special conditions for use statements apply to the FreeStyle Libre 3 (FSL3) (FSL3) device:

- Do not use the System in people less than 4 years of age. The System is not cleared for use in people under 4 years of age.
- Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.

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- The FreeStyle Libre 3 app installed on a phone is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.
- Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.
- Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See your health care professional to understand how long ascorbic acid is active in your body.
- Do not ignore symptoms that may be due to low or high blood glucose: if you are experiencing symptoms that are not consistent with the glucose readings, consult your health care professional.
- Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel or if the reading does not include a number.
- For you to receive alarms, they must be on and your device should be within 33 feet of you at all times. The transmission range is 33 feet unobstructed. If you are out of range, you may not receive alarms.
- If you suspect that the temperature may exceed 82°F (for example, in an unairconditioned home in summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
- Do not force close the App. The App must be running in the background to receive alarms. If you force close the App you will not receive alarms. Re-open the App to ensure you will receive alarms.

IV Device/System Characteristics:

A Device Description:

The subject devices are the FreeStyle Libre 2 (FSL2) Flash Glucose Monitoring System and the FreeStyle Libre 3 (FSL3) Continuous Glucose Monitoring System. Both systems utilize the FreeStyle Libre App with different app versions for the FSL2 and FSL3, and both app versions are available on Apple and Android mobile phone operating systems. The device descriptions of the FSL2 and FSL3 systems are unchanged from K210943 and K213996, respectively. As part of the current 510(k) the subject devices are receiving additional functionality called the "Libre Data Sharing API."

The Libre Data Sharing API is a cloud-based application programming interface (API) that is intended to enable communication of glucose data, including alarms, through the cloud from an FDA cleared Abbott iCGM system, consisting of an on-body sensor and a primary display device, to an authorized third-party organization ('client') software on digitally connected devices. The data transmitted by the API to an authorized client software can be used for specific and permitted use cases, including non-medical 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.

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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 connected iCGM system. 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 Abbott iCGM system, which directly receives the data from the sensor, continues to serve as a primary display device for the glucose data and alarms. As part of this 510(k) there are no modifications to the sensors, transmitters, or user interfaces of the FSL2 or FSL3 systems.

As a component of iCGM systems, the Libre Data Sharing API is subject to the applicable special controls defined in 21 CFR 862.1355. FDA determined that the technical design of the Libre Data Sharing API and the verification and validation testing provided in the current 510(k) are adequate to meet the iCGM special controls. In addition to these regulatory controls, Abbott Diabetes Care elected to use a "whitelist" approach to control access to the API, such that access by 3rd party developers will require prior authorization from Abbott Diabetes Care.

## Instrument Description Information:

1. Instrument Name:
FreeStyle Libre 2 Flash Glucose Monitoring System
FreeStyle Libre 3 Continuous Glucose Monitoring System

2. Specimen Identification:
Not applicable

3. Specimen Sampling and Handling:
Not applicable

4. Calibration:
Unchanged from K210943 for the FSL2 and K213996 for the FSL3.

5. Quality Control:
Not applicable

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.

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V Substantial Equivalence Information:

A Predicate Device Name(s):

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

FreeStyle Libre 3 Continuous Glucose Monitoring System

B Predicate 510(k) Number(s):

K210943, K213996

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K223537 | K210943 |
| --- | --- | --- |
| Device Trade Name | FreeStyle Libre 2 Flash Glucose Monitoring System | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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 | Same |

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| | 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. | |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| Application Programming Interfaces (APIs) | Enables users to share their glucose data with authorized client software. Can communicate iCGM data wirelessly and securely to and from digitally connected devices (client software) through a cloud-based communication method. | No API functionality |
| Device & Predicate Device(s): | K223537 | K213996 |
| --- | --- | --- |
| Device Trade Name | FreeStyle Libre 3 Continuous Glucose Monitoring System | FreeStyle Libre 3 Continuous Glucose Monitoring System |
| General Device Characteristic Similarities | | |
| Intended 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 | Same |

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VI Standards/Guidance Documents Referenced:

- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 6, 2017)
- Format for Traditional and Abbreviated 510(k)s (September 13, 2019)
- Multi-Function Device Products: Policy and Considerations (July 29, 2020)

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Performance established in K210943 for the FSL2 and K213996 for the FSL3.

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2. **Linearity:**
Previously established in K210943 for the FSL2 and K213996 for the FSL3.

3. **Analytical Specificity/Interference:**
Previously established in K210943 for the FSL2 and K213996 for the FSL3.

4. **Accuracy (Instrument):**
Previously established in K210943 for the FSL2 and K213996 for the FSL3.

5. **Carry-Over:**
Not Applicable

## B Other Supportive Instrument Performance Characteristics Data:

The following supportive instrument performance characteristics were established in prior 510(k) clearances for the FSL2 and FSL3 system, and are not affected by the addition of the Libre Data Sharing API:

- Human Factors
- Biocompatibility
- Sterilization
- Shelf Life and Stability
- Packaging Integrity/Shipping Integrity
- Electromagnetic Compatibility
- Electrical Safety
- Environmental Testing
- Blood Glucose Meter Functionality
- Interoperability

The following performance characteristics were verified or validated through studies of the current design:

- Software
- Cybersecurity

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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