Lingo Glucose System

K233655 · Abbott · SAF · May 29, 2024 · Clinical Chemistry

Device Facts

• Record ID: K233655
• Device Name: Lingo Glucose System
• Applicant: Abbott
• Product Code: SAF · Clinical Chemistry
• Decision Date: May 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2

Intended Use

The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

Device Story

Lingo Glucose System is an OTC biowearable for non-insulin users to monitor glucose-lifestyle correlations. System comprises a single-use, 14-day subcutaneous electrochemical biosensor and a smartphone app (iOS). Biosensor measures interstitial glucose via amperometric reaction; calculates glucose values internally; transmits data via Bluetooth Low Energy (BLE) to the app. App displays real-time glucose values, trends, and graphs (55-200 mg/dL range). No alerts or alarms provided. User applies sensor to upper arm using a disposable applicator. Device intended for wellness/lifestyle management; users must consult healthcare professionals before taking medical action based on output. Benefits include improved understanding of how diet and exercise affect glucose excursions.

Clinical Evidence

No new clinical trials conducted. Substantial equivalence supported by leveraging clinical data from the predicate FreeStyle Libre 2 (K222447). Statistical analysis confirmed that the predicate's clinical performance data, which included higher glucose variability in diabetic subjects, represents a worst-case scenario for the subject device. System accuracy met iCGM special controls requirements per 21 CFR 862.1355.

Technological Characteristics

Amperometric electrochemical sensor; subcutaneous insertion; 14-day wear. Materials identical to predicate (ISO 10993-1 compliant). BLE connectivity (2.4 GHz). IP27 water resistance. Sterilization via electron beam (ISO 11137). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and CISPR 11. Wireless coexistence per AAMI TIR69/ANSI C63.27.

Indications for Use

Indicated for people 18 years and older not on insulin to continuously measure, record, analyze, and display glucose values. Helps detect euglycemic and dysglycemic levels and understand impact of lifestyle/behavior modifications on glucose. Not for medical action without professional consultation.

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 (K222447)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 29, 2024

Abbott Diabetes Care Inc. Juni Sarkar Associate Director, Regulatory Affairs 1360 South Loop Road Alameda, California 94502

Re: K233655

Trade/Device Name: Lingo Glucose System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: SAF Dated: November 13, 2023 Received: November 14, 2023

Dear Juni Sarkar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely,

Yiduo Wu -S

for Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K233655

Device Name Lingo Glucose System

Indications for Use (Describe)

The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.

The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "a" on the left, followed by the words "Abbott" in bold, black letters on the top line, and "Diabetes Care" in smaller, black letters on the bottom line. The logo is simple and modern, and the use of blue and black gives it a professional look.

Lingo Glucose System Traditional 510(k)

#### 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: K233655

#### Submitter:

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

Applicant Contact: Juni Sarkar

Title: Associate Director, Regulatory Affairs Phone: [phone]

Correspondent Contact: Naveen Thuramalla Title: Divisional Vice President, Regulatory Affairs and New Medical Sensors Phone: [phone]

Date Prepared: May 29, 2024

#### Device Names and Classification:

| Name of Device: | Lingo Glucose System |
|---------------------|-------------------------------------------------|
| Common Name: | Integrated Continuous Glucose Monitoring System |
| Product Code | SAF |
| Regulatory Section: | 21 CFR 862.1355 |
| Classification: | Class II |
| Review Panel: | Clinical Chemistry |

#### Predicate Device

Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (K222447)

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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized "a" in blue on the left, followed by the words "Abbott" in bold black font and "Diabetes Care" in a smaller, regular black font. The logo is simple and professional, and it is likely used to represent the company and its products.

### Indications for Use:

Indications for Use:

The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic and dysglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise. impact glucose excursion.

The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

#### Device Description

The Lingo Glucose System (also referred to as 'System') is Abbott's latest biowearable evolution in health technology for glucose measurement. This system encourages users 18 years and older not on insulin, to understand how glucose impacts their body. The Lingo Glucose System includes the Lingo Glucose Biosensor and the Lingo App.

#### Lingo Biosensor

The Lingo Glucose Biosensor hardware and technology is based on the FDA-cleared FreeStyle Libre 2 (FSL2) sensor (K222447). The Biosensor is a single use disposable on-body Biosensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated electronics. The Biosensor can be worn for up for 14 days and transmits data to the Lingo App via Bluetooth Low Energy (BLE). Similar to the predicate device, a disposable Biosensor insertion device, consisting of a Biosensor Applicator and Biosensor Pack is used to assemble and apply the Biosensor to the back of the user's upper arm.

### Lingo App (iOS)

When downloaded on a compatible smartphone running on iOS, the Lingo App uses Near-Field Communication (NFC) to start a new Biosensor and uses BLE to receive glucose data from the Biosensor. The user can view real-time glucose value, trend arrow, and glucose graph on the app through a glucose range of 55-200 mg/dL. The Lingo App contains on-boarding materials with a self-selection questionnaire that a user must consent prior to using the device. The App does not provide any glucose or system alerts.

#### Substantial Equivalence

- A. Predicate Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System
- B. Predicate 510(k) Number(s): K222447
- C. Comparison with Predicate: The similarities and differences between the subject and the predicate device are highlighted in the tables below.

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Image /page/5/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 letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

## Table 1: Similarities with the Predicate Device

| Similarities | | |
|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device:<br>FreeStyle Libre 2 Flash Glucose Monitoring System<br>(K222447) | Subject Device:<br>Lingo Glucose System (K233655) |
| Intended Use | The System is intended to monitor interstitial fluid<br>glucose concentrations and communicate with digitally<br>connected devices. | Same |
| Principle of<br>Operation | Amperometric measurement of current proportional to<br>glucose concentration in interstitial fluid via glucose<br>oxidase chemical reaction | Same |
| Compatible sensor | FSL2 sensor is compatible with FreeStyle Libre 2 App | Same<br>Lingo Biosensor is compatible with the Lingo App |
| Compatible<br>operating systems<br>for the App | The App is compatible with Android and iOS enabled<br>smartphones. | Same<br>The Lingo App is compatible with iOS enabled<br>smartphones. |
| Clinical<br>Setting/Sites of Use | Home use | Same |
| Method of Sensor<br>Activation | Near Field Communication (NFC) | Same |
| Method of Data<br>Transfer from<br>Sensor | Bluetooth Low Energy (BLE) for glucose data transfer.<br>User-initiated scan via NFC required to display glucose<br>data | BLE - data automatically transfers without user-initiated<br>scan (streaming data) |
| Glucose Reading<br>Update Interval | Every 1 minute | Same |
| Real-Time Glucose<br>Information<br>Displayed | Glucose Value, Trend Arrow, and Glucose Graph | Same |
| Sensor Calibration | Factory Calibrated | Same |
| Compatible Sensor<br>Warmup time | 1 hour | Same |
| Anatomical Sensor<br>wear locations | Back of the upper arm | Same |
| Similarities | Predicate Device:<br>FreeStyle Libre 2 Flash Glucose Monitoring System<br>(K222447) | Subject Device:<br>Lingo Glucose System (K233655) |
| Glucose Calculation<br>Algorithm | ADC Glucose Algorithm established for the predicate device | Same |
| System<br>Components | On-body Sensor<br>(User assembles Sensor Applicator and Sensor Container<br>prior to applying the Sensor) | Same<br>On-body Sensor<br>(User assembles Biosensor Applicator and Biosensor<br>Container prior to applying the Biosensor) |
| | Compatible Receiver (App or Reader) | Compatible Receiver (App) |
| Operating<br>Temperature | 50 °F to 113 °F | Same |
| Biosensor Kit<br>Storage<br>Temperature | 36 °F to 82 °F | Same |
| Operating and<br>storage relative<br>humidity | 10-90%, non-condensing | Same |
| Biosensor water<br>resistance | IP27: Can withstand immersion into 3 ft (one meter) of<br>water for up to 30 minutes. Protected against insertion of<br>objects > 12 mm diameter. | Same |
| Operating and<br>Storage altitude | -1,250 ft (-381 meters) to 10,000 ft (3,048 meters) | Same |
| Radio Frequency | 2.402-2.480 GHz BLE; GFSK; 0 dBm EIRP | Same |
| Differences | | |
| | Predicate Device:<br>FreeStyle Libre 2 Flash Glucose Monitoring<br>System (K222447) | Subject Device:<br>Lingo Glucose System (K233655) |
| Indications for Use | The FreeStyle Libre 2 Flash Glucose Monitoring<br>System is a continuous glucose monitoring (CGM)<br>device with real time alarms capability indicated for<br>the management of diabetes in persons age 2 and<br>older. It is intended to replace blood glucose testing<br>for diabetes treatment decisions, unless otherwise<br>indicated.<br>The System also detects trends and tracks patterns<br>and aids in the detection of episodes of<br>hyperglycemia and hypoglycemia, facilitating both<br>acute and long-term therapy adjustments.<br>Interpretation of the System readings should be<br>based on the glucose trends and several sequential<br>readings over time.<br>The System is also intended to autonomously<br>communicate with digitally connected devices<br>including automated insulin dosing (AID) system.<br>The System can be used alone or in conjunction<br>with these digitally connected devices for the<br>purpose of managing diabetes. | The Lingo Glucose System is an over-the-counter (OTC)<br>integrated Continuous Glucose Monitor (iCGM) intended<br>to continuously measure, record, analyze and display<br>glucose values in people 18 years and older not on insulin.<br>The Lingo Glucose System helps to detect euglycemic and<br>dysglycemic glucose levels. The Lingo Glucose System<br>may also help the user better understand how lifestyle and<br>behavior modification, including diet and exercise, impact<br>glucose excursion.<br>The user is not intended to take medical action based on<br>the device output without consultation with a qualified<br>healthcare professional. |
| Availability to user | Prescription use only | Over the counter |
| Primary display device | FreeStyle Libre 2 Reader or FreeStyle Libre 2 App | Lingo App |
| Glucose Measuring<br>Range | 40 to 400 mg/dL | 55 to 200mg/dL |
| Differences | | |
| | Predicate Device:<br>FreeStyle Libre 2 Flash Glucose Monitoring<br>System (K222447) | Subject Device:<br>Lingo Glucose System (K233655) |
| Sensor Life | Up to 15 days | Up to 14 days |
| Glucose Alarms | Optional Alarms: Low Glucose and High Glucose<br>Mandatory Alarms: Urgent Low | There are no alarms for the Lingo Glucose System |
| Location of glucose<br>algorithm | Receiver (Reader or App) | Biosensor |
| BLE Transmission<br>Range | 20 feet unobstructed | 33 feet unobstructed |
| Clinical Application | Management of diabetes mellitus | The Lingo Glucose System is to encourage users to<br>understand the correlation between their glucose values<br>and their nutrition, exercise and daily activities. |
| Intended Use<br>Population | Persons with diabetes age 2 years and older | The Lingo Glucose System is intended for users 18 years<br>and older not on insulin |
| Situations Where<br>Fingerstick Test is<br>Required to Confirm<br>Sensor Reading<br>(Adjunctive Use) | • The user's symptoms do not match the glucose<br>values displayed by the device.<br>• The device does not show a glucose value<br>• During the first 12 hours of wear during which the<br>check blood glucose icon is displayed | The Lingo Glucose System does not require fingerstick<br>testing based on the intended use of the device.…