← Product Code [QLG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QLG) · K213996

# FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996)

_Abbott Diabetes Care, Inc. · QLG · May 26, 2022 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QLG/K213996

## Device Facts

- **Applicant:** Abbott Diabetes Care, Inc.
- **Product Code:** [QLG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QLG.md)
- **Decision Date:** May 26, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1355
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Software as a Medical Device, Pediatric

## 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.

## Device Story

System provides real-time continuous glucose monitoring (CGM) for diabetes management; consists of disposable subcutaneous sensor and Android mobile application. Sensor uses amperometric electrochemical principle to measure interstitial glucose; transmits data via Bluetooth Low Energy (BLE) to smartphone app. App displays real-time glucose values, trend arrows, and historical graphs; provides mandatory and optional glucose/system alarms. Used in home environment by patients (age 4+); app must run in background for alarm functionality. Data can be shared with cloud-based repositories (LibreView/LibreLinkUp) for caregiver viewing. System replaces blood glucose testing for treatment decisions; facilitates therapy adjustments by detecting hyperglycemia/hypoglycemia trends. Benefits include continuous monitoring without manual scanning, improved trend awareness, and automated alerts for glucose excursions.

## Clinical Evidence

No new clinical data provided. Analytical performance, precision, reproducibility, and accuracy were previously established in K212132. Current submission relies on software verification/validation, cybersecurity assessment, wireless coexistence testing (AAMI TIR69/ANSI C63.27), and EMC testing (IEC 60601-1-2) to support the addition of the Android application.

## Technological Characteristics

Amperometric electrochemical sensor; factory calibrated. Transmits via BLE (33 ft range). Android mobile app interface. Sensor worn up to 14 days; disposable. Software verification per EN 62304. Cybersecurity controls include risk management, CBOM, and malware-free manufacturing processes. EMC compliance per IEC 60601-1-2. Wireless coexistence per AAMI TIR69/ANSI C63.27.

## Regulatory 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) ([K210943](/device/K210943.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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

K213996

B Applicant

Abbott Diabetes Care Inc.

C Proprietary and Established Names

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  |

## II Submission/Device Overview:

A Purpose for Submission:

Modifications to the cleared FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 app) to display real-time glucose data via a Bluetooth-enabled Android device without scanning the Sensor.

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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K213996 - Page 2 of 10

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) 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.

### C Contraindication(s):
Due to an administrative error, the reference to wear period was erroneously included in the Contraindications section of the previous 510(k) Decision Summary. It is now removed from this section and added to the Special Conditions for Use Statements section below.

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

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 sensor can be worn up to 14 days. Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.

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.

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.

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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 FreeStyle Libre 3 (FSL3) Continuous Glucose Monitoring 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), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running on Android operating system. When used with the FSL 3 sensor cleared under K212132, the proposed mobile app allows the user to activate FSL3 sensors, provides real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph) thus allowing the user may make treatment decisions, and connect with cloud-based applications to store and share data (e.g. LibreView).

The device is intended for use in people with diabetes mellitus, age 4 and older. The user downloads the app from the Google Play Store for Android OS.

Principle of Operation

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The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historic 12-hour glucose results (glucose graph) that are presented on the App. The real-time glucose measurements and glucose arrows are calculated by the Sensor software based upon glucose sampling, also performed by the Sensor.

The Sensor is designed to measure glucose levels in the user's interstitial fluid through an amperometric electrochemical sensor component. The sensor tail is inserted into the subcutaneous tissue and generates an electrical current via the oxidation of glucose from the interstitial fluid. The FreeStyle Libre 3 System is intended for single patient use. The App can only pair to one Sensor at a time. The Sensor is disposable and may be worn up to 14 days. The Sensor automatically terminates after 14 days of use.

## System Components and Features

**Alarms**: The FSL3 App can issue the following glucose and system alarms:

- **Mandatory Alarms**: Urgent Low Glucose, Replace Sensor, Sensor Ended
- These alarms cannot be turned off or modified and will always sound regardless of the phone's sound and vibe or Do Not Disturb (DND) settings.
- **Optional Alarms**: Low Glucose Alarm, High Glucose Alarm, Signal Loss Alarm
- For the optional alarms above, the Override DND setting is turned on by default; therefore, the user receives these alarms regardless of the phone's sound, vibe or DND settings. If the user wishes to have the optional alarms follow the phone's sound and vibe settings, the user must turn off Override DND from the App.

**Hardware / Software compatibility**: The FreeStyle Libre 3 Continuous Glucose Monitoring System is intended for use with Field Communication (NFC) and BLE-enabled smartphones running compatible Android operating systems. The FSL3 app is compatible with FSL3 Sensors.

**Secondary Viewers**: LibreView and LibreLinkUp (LLU) provide a cloud-based repository for glucose measurement data and mobile app that allows caregivers to receive and view glucose data (including glucose alarms) from users who use the FSL3 App with their sensor. Secondary viewers are not intended to be used for immediate clinical decision making.

## B Instrument Description Information:

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

2. **Specimen Identification**:
N/A

3. **Specimen Sampling and Handling**:
N/A

K213996 - Page 4 of 10

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4. Calibration:

The sensor is factory calibrated and cannot be calibrated by the user.

5. Quality Control:

N/A

V Substantial Equivalence Information:

A Predicate Device Name(s):

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

B Predicate 510(k) Number(s):

K210943

C Comparison with Predicate(s):

Due to an administrative error, the primary display device was wrongly referenced to have only iOS operating system instead of iOS or Android operating systems in the previous 510(k) Decision Summary. It has since been corrected.

|  Device & Predicate Device(s): | K213996 | K210943  |
| --- | --- | --- |
|  Device Trade Name | Freestyle Libre 3
Continuous Glucose Monitoring System | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | 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 | Same  |

K213996 - Page 5 of 10

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K213996 - Page 6 of 10
|   | 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. |   |
| --- | --- | --- |
|  General Device Characteristic Differences |  |   |
|  Applicator Assembly | No assembly required | Assembly of sensor to applicator required  |
|  Primary display device | FreeStyle Libre 3 App | FreeStyle Libre 2 App (iOS or Android) or FreeStyle Libre 2 Reader  |
|  Transmitter Dimension | 2.9 mm height/ 21 mm diameter | 5 mm height/ 30 mm diameter  |
|  Information provided with glucose alarm | Alarm type, glucose result and trend arrow | Alarm type  |
|  Method of Data transfer from Sensor | Bluetooth Low Energy (BLE) for both glucose data and alarms | BLE for glucose alarms. User-initiated scan via NFC required to display glucose data  |
|  BLE communication range | 33 feet unobstructed | 20 feet unobstructed  |

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VI Standards/Guidance Documents Referenced:

Due to an administrative error, two references were erroneously included in the previous 510(k) Decision Summary. They have since been removed from this section.

- 21 CFR 862.1355 integrated continuous glucose monitoring system (iCGM) special controls
- ISO 14971: 2019 Medical Devices – Application of risk management to medical devices
- ANSI AAMI 60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety
- AAMI TIR69: 2017, Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems
- ANSI C63.27-2017, American National Standard for Evaluation of Wireless Coexistence
- ANSI AAMI IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices
- AAMI / ANSI HE75: 2009/(R)2018, Human Factors Engineering - Design of Medical Devices
- AAMI TIR57: 2016, Principles for medical device security – Risk management
- IEC 60601-1-2:2014-02 Edition 4.0, General requirements for basic safety and essential performance – Collateral standard: Electromagnetic
- IEC 62304: 2006/A1:2016, Medical device software – Software life cycle processes
- ISO 15223-1:2016, Medical device – Symbols to be used with medical device labels, labeling and information to be supplied – Pt 1
- AAMI / ANSI / ISO 10993-1: 2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process
- ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and package
- ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- Applying Human Factors and Usability Engineering to Medical Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Electromagnetic Compatibility (EMC) of Medical Devices
- Radio Frequency Wireless Technology in Medical Devices
- Multiple Function Device Products: Policy and Considerations
- Policy for Device Software Functions and Mobile Medical Applications
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.

K213996 - Page 7 of 10

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VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
Previously established in K212132.

2. Linearity:
The reportable range for the System is 40 to 400 mg/dL.

3. Analytical Specificity/Interference:
Previously established in K212132.

4. Accuracy (Instrument):
Previously established in K212132.

5. Carry-Over:
N/A

B Other Supportive Instrument Performance Characteristics Data:

The following supportive instrument performance characteristics were established in K212132 unless mentioned otherwise, and are not affected by the addition of the Android App in the current 510(k):

- Sterilization
- Biocompatibility
- Environmental testing
- Shelf-life stability
- Packaging integrity/shipping integrity
- Mechanical engineering
- Interoperability
- Human Factors

Human factors and usability testing of the FreeStyle Libre 3 System was leveraged from K210943.

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

Software Verification and Validation

K213996 - Page 8 of 10

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Software verification and validation testing was conducted to confirm that the software used in the FreeStyle Libre 3 System performed in accordance with established specifications, EN 62304 and FDA Guidance document “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” May 11, 2005. Evaluation activities included unit, system integration (SIT), and system level testing which verified functionality of the device against established software requirements. Results of the software executed protocols for FreeStyle Libre 3 System met the acceptance criteria and therefore supports that the System’s Android App software is acceptable for its intended use.

## Cybersecurity

Abbott Diabetes Care (ADC) has provided cybersecurity risk management documentation for the FreeStyle Libre 3 System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System. For each identified threat and vulnerability risk event scenario, risk assessment of impact to confidentiality, integrity, and availability was performed and documented within the cybersecurity risk management documentation. Risk mitigation controls have been implemented and tested.

ADC provides a comprehensive cybersecurity bill of materials (CBOM) describing third party software components utilized and detailing support status and known vulnerabilities for each off-the-shelf (OTS) software component. In addition, ADC has controls and processes in place to ensure continued support for keeping the device secure and to ensure that the device firmware, software and components are malware free. Additional controls are also in place in manufacturing through distribution to ensure that the medical device firmware and software are malware free from point of origin to the hands of the end user.

## Wireless Coexistence

The FreeStyle Libre 3 System underwent coexistence testing in the presence of common RF interfering devices that are likely to be encountered by users in a home environment. A representative set of devices known to operate in the same frequency band (2.4 GHz) was selected and tested following methods consistent with AAMI TIR69 and ANSI C63.27. The test results showed that the FreeStyle Libre 3 System could tolerate interference generated by these RF interfering devices and still meet the target performance criteria.

## Electrical Safety and Electromagnetic Compatibility

Electrical safety data was leveraged from K212132 as the Sensor has not changed and the app only interacts with the Sensor via NFC and BLE radios on the compatible mobile phone (which independently needs to comply with applicable electrical safety standards).

Electromagnetic Compatibility (EMC) testing (radiated emissions, radiated immunity and magnetic field immunity) was performed to verify that the system was able to withstand electromagnetic interference in compliance with IEC 60601-1-2:2014. The FreeStyle Libre 3 System was tested with six (6) compatible smartphones running Android OS. A risk management process was used to evaluate the basic safety and essential performance of the FreeStyle Libre 3 System (with FreeStyle Libre 3 App) per IEC 60601-1:2005(r)2012. Previous testing from K212132 for electrostatic discharge (ESD) and other device EMC aspects is leveraged.

K213996 - Page 9 of 10

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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.

K213996 - Page 10 of 10

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QLG/K213996](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QLG/K213996)

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