Livongo Blood Glucose Monitoring System (BG1000)

K200277 · Livongo Health, Inc. · NBW · Jun 4, 2020 · Clinical Chemistry

Device Facts

• Record ID: K200277
• Device Name: Livongo Blood Glucose Monitoring System (BG1000)
• Applicant: Livongo Health, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000). The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared. The system is for in vitro diagnostic use and is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.

Device Story

Handheld, cellular-connected blood glucose meter; uses amperometric electrochemical test strips to measure glucose in capillary whole blood from fingertips. User applies blood to strip; meter displays glucose level (40-600 mg/dL) on touch-panel screen; stores data in memory; transmits data via cellular network to secure server. Used by patients with diabetes in home settings for self-monitoring. Features include logs, graphs, and averages. Hardware includes camera, microphone, 3-axis accelerometer, and vibrator motor (hardware support only). Output aids patients in diabetes management and treatment decisions.

Clinical Evidence

Lay user evaluation study (n=383) compared capillary blood glucose results against YSI 2300 laboratory comparator. Results showed 99.7% of samples within ±15% and 100% within ±20% of comparator across the measuring range. Extreme glucose value study (n=139) confirmed performance at <80 mg/dL and >250 mg/dL. Bench testing validated linearity, precision (CV 2.2-3.3%), hematocrit interference (10-70%), altitude (up to 10,000 ft), and sample volume (0.6 μL).

Technological Characteristics

Amperometric glucose measurement using FAD-GDH enzyme. Measurement range 40-600 mg/dL. Handheld form factor with touchscreen interface. Connectivity via cellular network. Powered by AC adapter/USB. Disinfection validated for 260 cycles using PDI Super Sani-Cloth. Compliant with electrical safety and EMC standards.

Indications for Use

Indicated for self-testing by people with diabetes at home to monitor glucose levels in fresh capillary whole blood from fingertips as an aid in diabetes control programs. Not for diagnosis or screening of diabetes; not for use on neonates.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• On Call Sure Blood Glucose Monitoring System (K181527)
• On Call Sure Sync Blood Glucose Monitoring System (K181527)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 4, 2020

Livongo Health, Inc. Jacob Gendler Regulatory Affairs Project Manager 150 W. Evelyn Ave, Suite 150 Mountain View, CA 94041

Re: K200277

Trade/Device Name: Livongo Blood Glucose Monitoring System (BG1000) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 2, 2020 Received: May 4, 2020

## Dear Jacob Gendler:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Marianela Perez-Torres, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K200277

Device Name

Livongo Blood Glucose Monitoring System (BG1000)

Indications for Use (Describe)

The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000).

The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared.

The system is for in vitro diagnostic use and is not intended for the diagnosis of or diabetes, nor intended for use on neonates.

| 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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## 510(k) Summary

### K200277

#### 1. Submitter

Livongo Health, Inc. 150 W. Evelyn Ave, Suite 150 Mountain View, CA 94041 USA Phone: [phone] Email: [e-mail] Contact: Jacob Gendler, Regulatory Affairs Project Manager

Date Prepared: May 11, 2020

| Proprietary Name | Livongo Blood Glucose Monitoring System (BG1000) |
|------------------|----------------------------------------------------|
| Common Name | Blood Glucose Monitoring System |
| Class | II |
| Regulation | 21 CFR §862.1345 |
| Product Code | NBW; System, Test, Blood Glucose, Over The Counter |

#### 2. Device Information

### 3. Predicate Device

On Call Sure / On Call Sure Sync Blood Glucose Monitoring System (K181527)

### 4. Device Description

The Livongo Blood Glucose Monitoring System (BG1000) is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components:

- Livongo Blood Glucose Meter (BG1000) ("Livongo meter") ●
- Livongo Blood Glucose Test Strips (BG1000) ("Livongo test strips")
- Livongo Lancing Device - class I accessory
- Livongo Lancets
- Livongo Level 1 Control Solution
- Livongo Level 2 Control Solution
- AC Adapter (wall charger) and USB Charger Set
- Carrying Case

The Livongo meter is a cellular-connected handheld device that monitors glucose in the blood to help with the management and treatment of diabetes. The meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs. The blood glucose levels are displayed on the screen and stored in the meter's memory, and may also be transmitted over a cellular network to a secure server.

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The Livongo test strips will be packaged in 50 count of strips in sealed vials.

The Livongo Control Solutions consist of an aqueous based mixture prepared with a known amount of glucose concentration. It is available in two levels, Level 1 and Level 2.

## 5. Indications for Use

The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000).

The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for singlepatient use and should not be shared.

The system is for in vitro diagnostic use and is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.

## 6. Comparison to Predicate Device

The table below compares the Livongo Blood Glucose Management System (BG1000) with the predicate device (K181527).

| Feature | This Device | Predicate Device (K181527) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Livongo Blood Glucose Monitoring System (BG1000) | On Call Sure / On Call Sure Sync Blood Glucose Monitoring System |
| Meter Model No. | BG1000 | OGM-211 |
| Indications for Use | The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000).<br><br>The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared | The On Call Sure and On Call Sure Sync Blood Glucose Monitoring Systems are comprised of the On Call Sure or On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips.<br><br>The On Call Sure and On Call Sure Sync Blood Glucose Monitoring Systems are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure and On Call Sure Sync Blood Glucose Monitoring Systems are intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure and On Call Sure Sync Blood Glucose Monitoring |
| Feature | This Device | Predicate Device (K181527) |
| | The system is for in vitro diagnostic<br>use and is not intended for the<br>diagnosis of or screening for diabetes,<br>nor intended for use on neonates. | Systems are intended for single-patient use<br>and should not be shared. |
| | | The On Call Sure and On Call Sure Sync<br>Blood Glucose Monitoring Systems are for<br>in vitro diagnostic use. The On Call Sure andOn Call Sure Sync Blood Glucose<br>Monitoring Systems are not intended for<br>the diagnosis of or screening for diabetes,<br>nor intended for use on neonates.<br>Alternative site testing should be done only<br>during steady-state times (when glucose is<br>not changing rapidly). |
| Detection<br>Method | Amperometric electrochemical | Same |
| Enzyme | Glucose Dehydrogenase (FAD-GDH) | Same |
| Calibration<br>Coding | Auto-coding | Same |
| Test Range | 40 - 600 mg/dL | Same |
| Units of<br>Measurement | mg/dL | Same |
| Result<br>Calibration | Plasma-equivalent, calibrated by using<br>YSI (Model 2300 STAT PLUS) Glucose<br>Analyzer reference instrument, which<br>is traceable to NIST reference<br>standard. | Same |
| Memory | 1000 records with time and date | Same |
| Day Average | 7, 14, 30, 60 and 90-day averages | Same |
| Sample Type | Capillary whole blood | Same |
| Sample Sites | Fingertip only | Fingertip, forearm, palm |
| Sample Volume | 0.6 µL | Same |
| Sample Test<br>Time | 5 seconds | Same |
| Hematocrit<br>Range | 10 - 70% | Same |
| Altitude Study | Up to 10000 feet | Same |
| Operating<br>Temperature | 41-113°F (5-45°C) | Same |
| Operating<br>Relative<br>Humidity | 10-90% | Same |
| Automatic<br>Shutoff | 120 seconds | Same |
| Power Source | Rechargeable 3.85V lithium ion<br>battery | Two CR 2032 3.0V coin cell batteries |
| Battery Charge<br>Time | <4.5 hours | N/A |
| Feature | This Device | Predicate Device (K181527) |
| AC adapter | Yes | No |
| Meter Size | 130 x 60 x 12.7 mm | 90 x 60 x 16 mm |
| Meter Weight | 142 g | 72 g (with batteries installed) |
| Meter Color | Blue & white | Navy blue or black |
| Strip Ejector | No | Yes |
| Meter Screen<br>Size | 4" | 2.25" |
| Meter User<br>Interface | Touch-panel LCM | Monochrome display with push button<br>interface |
| Camera | Yes (hardware support only) | No |
| Speaker | Yes | Same |
| Microphone | Yes (hardware support only) | No |
| Strip light | 1 | 0 |
| 3-axis<br>accelerometer | 1 (hardware support only) | 0 |
| Vibrator motor | Yes (hardware support only) | No |
| Electrical Safety<br>Testing | IEC 61010 compliant | Same |
| EMC Testing | IEC 60601-1-2 compliant | Same |
| Method<br>Comparison/<br>User Evaluation | Per FDA guidance "Self-Monitoring<br>Blood Glucose Test Systems for Over-<br>the-Counter Use" | Same |

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## 7. Summary of Non-Clinical Performance

Design verification and validation testing was performed to ensure the Livongo Blood Glucose Monitoring System (BG1000) met design specifications and requirements. Testing is summarized below.

## Within-Run Precision Evaluation

Ten replicate assays were each run on ten Livongo meters using three strip lots. Heparinized venous blood samples at six concentration levels were used in the testing. The results are summarized below.

| Glucose Level | Mean | Standard Deviation or % CV |
|---------------|-------------|----------------------------|
| 1 | 45.8 mg/dL | 1.49 mg/dL |
| 2 | 78.2 mg/dL | 2.33 mg/dL |
| 3 | 126.3 mg/dL | 2.7% |
| 4 | 192.9 mg/dL | 2.7% |
| 5 | 337.6 mg/dL | 2.5% |
| 6 | 491.7 mg/dL | 2.5% |

### Intermediate Precision Evaluation

Ten replicate assays were each run on ten Livongo meters using test strips from three lots. Heparinized venous blood samples at six concentration levels were used in the testing. The results are summarized below.

| Glucose Level | Mean | Standard Deviation or % CV |
|---------------|-------------|----------------------------|
| 1 | 46.3 mg/dL | 1.41 mg/dL |
| 2 | 89.7 mg/dL | 2.30 mg/dL |
| 3 | 141.5 mg/dL | 2.9% |
| 4 | 229.3 mg/dL | 2.3% |
| 5 | 359.2 mg/dL | 2.2% |
| 6 | 546.4 mg/dL | 2.2% |

### Linearity Evaluation

Blood samples were prepared to 42±2% hematocrit level and were run on 10 meters using test strips from three lots. Samples were prepared at eleven blood glucose concentration levels as shown in the table below.

| Level | Glucose Concentration Level |
|-------|-----------------------------|
| 25 | 20 -30 mg/dL |
| 50 | 40 - 60 mg/dL |
| 80 | 70 - 90 mg/dL |
| 110 | 100-120 mg/dL |
| 170 | 160-180 mg/dL |
| 220 | 210-230 mg/dL |
| 330 | 310-350 mg/dL |
| 450 | 430-470 mg/dL |
| 550 | 520-580 mg/dL |
| 650 | 600-700 mg/dL |

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| Strip Lot | Slope | Y-Intercept | R2 |
|-----------|-------|-------------|--------|
| 1 | 0.988 | 2.1 | 0.9968 |
| 2 | 0.980 | 0.5 | 0.9984 |
| 3 | 0.976 | 3.3 | 0.9974 |

Linear regression analysis results are shown in the table below.

The results of the linearity study support the glucose measurement range of 40-600 mg/dL for the Livongo Blood Glucose Monitoring System (BG1000).

### Interference – Hematocrit

Hematocrit interference was tested using whole blood samples that were prepared to hematocrit levels across the claimed hematocrit range at 5% intervals with six glucose concentration levels. Test strips from three strip lots were used for testing, with bias compared to a comparator method (YSI).

The bias of measurement was within ±10 mg/dL for glucose concentration level 1. For glucose concentration levels 2-6, the bias of measurement was within ±8%, and no individual value had a bias of greater than 15%, confirming accurate readings for the specified hematocrit range of 10%-70%.

### Flex Studies

Flex studies were used to validate the insensitivity of the test system to performance variation due to factors that may contribute to erroneous results when used in home use settings rather than in laboratory or professional healthcare settings. The robustness of the system was validated through mechanical vibration and shock testing, operating conditions (temperature and humidity) testing, altitude effects testing, and stability testing. Additional sources of error that were tested included samples outside the measuring range, short sample detection, sample perturbation, intermittent sampling, and testing with used strips. In all of the tests, the system operated within its specified operating ranges even under stress conditions, and errors were correctly displayed when outside the meter's operating ranges.

### Electromagnetic Interference and Electrical Safety

The system passed electrical and safety testing according to national and international standards including IEC 61010-1, IEC 61010-2-101, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, and IEC 61000-4-8.

The li-ion battery is certified to IEC 62133.

The system passed EMC testing to national and international standards including IEC 60601-1-2, FCC 47 CFR 15 Part B, and PTCRB.

### Software

Based on the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005, testing and documentation for Moderate level of concern software was completed.

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## 8. Summary of Clinical Performance

A clinical (user evaluation) study was conducted with the intended user, lay persons using the Livongo Blood Glucose Monitoring System (BG1000) to evaluate in a simulated home environment. The study data were presented evaluating the system accuracy of the Livongo Blood Glucose Monitoring System (BG1000) compared to the YSI 2300 Stat Plus Glucose Analyzer (K913806). Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the Livongo Blood Glucose Monitoring System (BG1000) comparable to the comparator YSI 2300 obtained by trained technicians. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User Guide and the overall performance of the Livongo Blood Glucose Monitoring System (BG1000).

## 9. Discussion of Substantial Equivalence

The results of bench performance and clinical performance testing demonstrate that the candidate device is substantially equivalent to the predicate device, On Call Sure / On Call Sure Sync Blood Glucose Monitoring System (K181527).