The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Device Story
System monitors interstitial fluid glucose via subcutaneously implanted electrochemical sensor; glucose oxidase enzyme oxidizes glucose to generate current proportional to glucose concentration. Sensor transmits data via NFC/BLE to Reader or smartphone App. App/Reader displays glucose values, trends, and alarms. New features include FreeStyle Libre 3 Reader as primary display and 'Silent Mode' for App alarms (silences alerts for up to 6 hours). Intended for home use by patients; requires prescription. Output aids patient/physician in diabetes management, therapy adjustments, and integration with automated insulin dosing (AID) systems.
Clinical Evidence
No new clinical data provided. Pivotal clinical studies for predicate devices (K222447) were leveraged. Performance characteristics (precision, reproducibility, analytical specificity, interference) were previously established. Human factors and usability testing were conducted to validate the 'Silent Mode' feature and FSL3 Reader integration.
Technological Characteristics
Electrochemical glucose oxidase sensor; silver oxide battery; NFC/BLE connectivity; Reader and smartphone App interfaces. Materials and sensor electronics identical to predicates. Software verification per IEC 62304. Wireless coexistence per AAMI TIR69/ANSI C63.27. Cybersecurity risk management per AAMI TIR57.
Indications for Use
Indicated for management of diabetes in persons age 2 and older. Intended to replace blood glucose testing for treatment decisions. Contraindicated for use during MRI, CT scan, 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 3 Continuous Glucose Monitoring System (K222447)
FreeStyle Libre 2 Flash Glucose Monitoring System (K222447)
Reference Devices
FreeStyle Precision Neo Blood Glucose test strips (K171941)
K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System · Abbott Diabetes Care, Inc. · Feb 21, 2023
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2023
Abbott Diabetes Care, Inc. Katherine Doll Kanne Principal Regulatory Affairs Specialist 1360 South Loop Road Alameda, CA 94502
# Re: K223435
Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System: 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: QBJ, NBW Dated: March 13, 2023 Received: March 14, 2023
Dear Katherine Doll Kanne:
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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listing (21 CFR Part 807); labeling (21 CFR Part
Page 2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is by Paula V. Caposino -S. The date of the signature is 2023.04.13. The time of the signature is 13:12:26 -04'00'.
Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology 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) K223435
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System
### Indications for Use (Describe)
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# Indications for Use
510(k) Number (if known) K223435
Device Name
FreeStyle 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 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.
### ડ. 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: K223435
### 5.1 Submitter:
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Katherine Doll Kanne Title: Principal Regulatory Affairs Specialist Phone: (612) 394-9209 Fax: (510) 864-4791
Date Prepared: April 13, 2023
#### 5.2 Device Names and Classification:
| Name of Device: | FreeStyle Libre 3 Continuous Glucose Monitoring System |
|---------------------|---------------------------------------------------------------------|
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QBJ, NBW |
| Review Panel: | Clinical Chemistry |
| | |
| Name of Device: | FreeStyle Libre 2 Flash Glucose Monitoring System |
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QBJ, NBW |
| Review Panel: | Clinical Chemistry |
#### 5.3 Predicate Device
Predicate Devices: Freestyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System (K222447)
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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 abstract shape on the left, followed by the word "Abbott" in bold black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font. The logo is clean and professional, conveying a sense of trust and reliability.
#### 5.4 Indications for Use:
#### 5.4.1 FreeStyle Libre 3 Continuous Glucose Monitoring System
### 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 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
### Contraindication
MRVCT/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.
#### 5.4.2 FreeStyle Libre 2 Flash Glucose Monitoring System
### 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 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
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Image /page/6/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The logo is clean and professional, suggesting a focus on healthcare and technology.
# Contraindication
MRVCT/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.
### ર્સ્ડ Device Description
The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use.
The FSL3 System consists of the FreeStyle Libre 3 Sensor and either the FreeStyle Libre 3 Reader or the FreeStyle Libre 3 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL3 Reader and FSL3 App do not interact with each other.
The FSL2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL2 Reader and FSL2 App do not interact with each other.
Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.
### FreeStyle Libre 3 Continuous Glucose Monitoring System 5.5.1
# 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. During Sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has a 15-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
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Image /page/7/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.
# FreeStyle Libre 3 App (iOS and Android)
- When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses Near Field Communication (NFC) 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 Google Play Store and a list of compatible devices is accessible in the App via the Help feature or product website.
# FreeStyle Libre 3 Reader
- The FreeStyle Libre 3 Reader is a small handheld device that is powered by a lithium-● ion rechargeable battery and uses NFC communication to start new Sensors and BLE communication to display glucose data and issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
### 5.5.2 FreeStyle Libre 2 Flash Glucose Monitoring System
# FreeStyle Libre 2 Sensor
- The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
## FreeStyle Libre 2 App (iOS and Android)
- When downloaded to a compatible smartphone, the FreeStyle Libre 2 App uses NFC ● communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms. As a mobile application, the FreeStyle Libre 2 App allows connectivity with cloud-based applications. The FreeStyle Libre 2 App is distributed using the Apple App Store and Google Play Store, and a list of compatible devices is accessible in the App via the Help feature or product website.
FreeStyle Libre 2 Reader
- The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
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Image /page/8/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top right. Below "Abbott" is the text "Diabetes Care" in a regular black font. The logo is clean and professional, representing the company's brand identity.
#### 5.6 Substantial Equivalence
The similarities and differences between the subject and the predicate devices are highlighted in the tables below.
| Similarities | | |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Subject Device: FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | Predicate Device: FreeStyle Libre 3<br>Continuous Glucose Monitoring System<br>(K222447) |
| Indications for Use | The FreeStyle Libre 3 Continuous Glucose Monitoring System is a<br>real time continuous glucose monitoring (CGM) device with alarms<br>capability indicated for the management of diabetes in persons age<br>2 and older. It is intended to replace blood glucose testing for<br>diabetes treatment decisions, unless otherwise indicated.<br>The System also detects trends and tracks patterns and aids in the<br>detection of episodes of hyperglycemia and hypoglycemia,<br>facilitating both acute and long-term therapy adjustments.<br>Interpretation of the System readings should be based on the<br>glucose trends and several sequential readings over time.<br>The System is also intended to autonomously communicate with<br>digitally connected devices, including automated insulin dosing<br>(AID) systems. The System can be used alone or in conjunction<br>with these digitally connected devices for the purpose of managing<br>diabetes. | Same |
| Intended Use Population | Persons with diabetes age 2 and older | Same |
| Device Type | Integrated CGM | Same |
| Compatible operating systems<br>and hardware platform for<br>App | App is compatible with iOS and Apple smartphone; Android<br>operating system (OS) and Android-enabled smartphones. | Same |
| Principle of Operation | Amperometric measurement of current proportional to glucose<br>concentration in interstitial fluid via glucose oxidase chemical<br>reaction | Same |
| Similarities | | |
| | Subject Device: FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | Predicate Device: FreeStyle Libre 3<br>Continuous Glucose Monitoring System<br>(K222447) |
| Test Range | 40 to 400 mg/dL | Same |
| Clinical Application | Management of diabetes mellitus | Same |
| Clinical Setting/Sites of Use | Home use | Same |
| Data Displayed | Current glucose value, current glucose trend, graph with recent<br>glucose history, user entered events | Same |
| Method of Sensor Activation | Near Field Communication (NFC) | Same |
| Wireless communications<br>protocol | NFC: 13.56 MHz RFID<br>Bluetooth Low Energy (BLE) | Same |
| Method of Data Transfer<br>from Sensor | Bluetooth Low Energy (BLE). Data automatically transfers without<br>user initiated scan (streaming data). | Same |
| BLE Communication Range | 33 feet unobstructed | Same |
| Sensor Glucose Algorithm | ADC Glucose Algorithm established for the predicate device | Same |
| Location of glucose algorithm | Sensor | Same |
| Glucose Reading Update<br>Interval | Every 1 minute | Same |
| Glucose History | Graph and other reports can be used to view logged data | Same |
| Glucose Trend 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 |
| App method of<br>communication and<br>connectivity with cloud-based<br>applications | App can communicate wirelessly to LibreView. Through<br>LibreView, can communicate to LibreLinkUp App. | Same |
| Situations Where Fingerstick<br>Test is Required to Confirm<br>Sensor Reading (Adjunctive<br>Use) | The user's symptoms do not match the glucose values displayed by the device. The device does not show a glucose value | Same |
| Similarities | | |
| | Subject Device: FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | Predicate Device: FreeStyle Libre 3<br>Continuous Glucose Monitoring System<br>(K222447) |
| | During the first 12 hours of wear during which the check blood glucose icon is displayed | |
| Mandatory Alarms | Glucose Alarm: Urgent Low Glucose | Same |
| | System Alarm: Replace Sensor, Sensor Ended, Check Sensor, App<br>Stopped (iOS only) | |
| Optional Alarms | Glucose Alarms: Low Glucose Alarm, High Glucose Alarm | Same |
| | System Alarm: Signal Loss Alarm | |
| Information provided with<br>glucose alarm | Alarm type, glucose result and trend arrow | Same |
| Compatible Sensors | FreeStyle Libre 3 Sensor | Same |
| Sensor Calibration | Factory Calibrated | Same |
| Compatible Sensor Warmup<br>time | 1 hour | Same |
| Compatible Sensor Life | Up to 15 days (automatic Sensor shut off) | Same |
| Anatomical Sensor wear<br>locations | Back of the upper arm | Same |
| Sensor Tail Dimension | 5.5 mm depth, 0.3 mm width | Same |
| Application Programming<br>Interfaces (APIs) | Enables users to share their glucose data with authorized client<br>software.<br><br>Can communicate iCGM data wirelessly and securely to and<br>from digitally connected devices (client software) through a<br>cloud based communication method. | Same |
| Differences | | |
| | Subject Device: FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | Predicate Device: FreeStyle Libre 3 Continuous<br>Glucose Monitoring System (K222447) |
| System Components | FreeStyle Libre 3 Sensor<br>FreeStyle Libre 3 App (iOS or Android)<br>FreeStyle Libre 3 Reader | FreeStyle Libre 3 Sensor<br>FreeStyle Libre 3 App (iOS or Android) |
| Primary display device | FreeStyle Libre 3 App (iOS or Android) or<br>FreeStyle Libre 3 Reader | FreeStyle Libre 3 App (iOS or Android) only |
| Reader method of<br>communication and<br>connectivity with cloud-<br>based applications | Reader can communicate and connect with LibreView through<br>the USB port connection with the desktop computer. | No Reader |
| Blood Glucose Meter (BGM) | An integrated BGM is provided with the Reader | No Reader |
| | While using the App, user must have access to a blood glucose<br>monitoring system as the App does not provide one. | While using the App, user must have access to a<br>blood glucose monitoring system as the App does<br>not provide one. |
| Silent Mode Feature | App user has option to silence the Urgent Low Glucose Alarm,<br>Low Glucose Alarm, High Glucose Alarm and Signal Loss<br>Alarm. This feature is turned off by default but can be turned on<br>by the user for a maximum of 6 hours. | No Silent Mode feature |
### FreeStyle Libre 3 Continuous Glucose Monitoring System 5.6.1
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, suggesting a focus on healthcare and technology.
{11}------------------------------------------------
Image /page/11/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 font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized blue "a" symbol on the left and the text "Abbott Diabetes Care" on the right. The word "Abbott" is in bold, while "Diabetes Care" is in a regular font.
### 5.6.2 FreeStyle Libre 2 Flash Glucose Monitoring System
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