(121 days)
No
The summary describes a standard blood glucose monitoring system with data storage and transmission capabilities. There is no mention of AI/ML algorithms being used for analysis, interpretation, or prediction. The performance studies focus on analytical accuracy and user performance, not AI/ML model validation.
No
The device is a diagnostic tool used to measure blood glucose levels, aiding in the monitoring of diabetes. It does not directly treat or provide therapy for the condition.
Yes
Explanation: The device is a blood glucose monitoring system intended for the quantitative measurement of glucose, which is used as an aid to monitor the effectiveness of diabetes control programs. It is explicitly stated as being for "in vitro diagnostic use."
No
The device description explicitly lists multiple hardware components including a blood glucose meter, test strips, lancing device, lancets, control solutions, AC adapter, USB charger, and carrying case. While the meter has software features, it is part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The system is for in vitro diagnostic use..."
- Nature of the Test: The system measures glucose in fresh capillary whole blood. This is a test performed in vitro (outside the body) on a biological sample.
- Purpose: The system is intended as an aid to monitor the effectiveness of diabetes control programs. This is a diagnostic purpose, even though it's for monitoring and not initial diagnosis.
The device description and performance summaries further support this by detailing the components used for the in vitro test (meter, test strips, control solutions) and the studies conducted to evaluate the accuracy and performance of the in vitro measurement.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Self-testing by people with diabetes at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Results summarized by Mean, Standard Deviation or % CV.
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. Results summarized by Mean, Standard Deviation or % CV.
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. Linear regression analysis results show slope, Y-Intercept, and R² for each strip lot. Results support glucose measurement range of 40-600 mg/dL.
Interference – Hematocrit: Hematocrit interference was tested using whole blood samples prepared to hematocrit levels across the claimed range at 5% intervals with six glucose concentration levels. Test strips from three lots were used, with bias compared to YSI. Bias was within ±10 mg/dL for level 1 glucose and within ±8% for levels 2-6, with no individual value exceeding 15%.
Flex Studies: Validated insensitivity to performance variation due to mechanical vibration and shock, operating conditions (temperature and humidity), altitude effects, and stability. Also tested samples outside measuring range, short sample detection, sample perturbation, intermittent sampling, and used strips. System operated within specified ranges, displaying errors correctly when outside operating ranges.
Electromagnetic Interference and Electrical Safety: Passed electrical and safety testing according to IEC 61010-1, IEC 61010-2-101, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, and IEC 61000-4-8. Li-ion battery certified to IEC 62133. Passed EMC testing to IEC 60601-1-2, FCC 47 CFR 15 Part B, and PTCRB.
Software: Testing and documentation for Moderate level of concern software completed per FDA guidance.
Clinical Performance (User Evaluation): A study was conducted with lay persons using the Livongo Blood Glucose Monitoring System (BG1000) in a simulated home environment. System accuracy was evaluated against the YSI 2300 Stat Plus Glucose Analyzer (K913806). Results indicated that non-professional, inexperienced lay persons obtained blood glucose readings comparable to those obtained by trained technicians using the YSI 2300. Participants were satisfied with the ease of operation and overall performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
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.(b)
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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
K200277
1. Submitter
Livongo Health, Inc. 150 W. Evelyn Ave, Suite 150 Mountain View, CA 94041 USA Phone: +1 (612) 418-4648 Email: jacob.gendler@livongo.com 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.
4
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). |
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.
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
use and is not intended for the
diagnosis of or screening for diabetes,
nor intended for use on neonates. | Systems are intended for single-patient use
and should not be shared. |
| | | The On Call Sure and On Call Sure Sync
Blood Glucose Monitoring Systems are for
in vitro diagnostic use. The On Call Sure andOn Call Sure Sync Blood Glucose
Monitoring Systems are not intended for
the diagnosis of or screening for diabetes,
nor intended for use on neonates.
Alternative site testing should be done only
during steady-state times (when glucose is
not changing rapidly). |
| Detection
Method | Amperometric electrochemical | Same |
| Enzyme | Glucose Dehydrogenase (FAD-GDH) | Same |
| Calibration
Coding | Auto-coding | Same |
| Test Range | 40 - 600 mg/dL | Same |
| Units of
Measurement | mg/dL | Same |
| Result
Calibration | Plasma-equivalent, calibrated by using
YSI (Model 2300 STAT PLUS) Glucose
Analyzer reference instrument, which
is traceable to NIST reference
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
Time | 5 seconds | Same |
| Hematocrit
Range | 10 - 70% | Same |
| Altitude Study | Up to 10000 feet | Same |
| Operating
Temperature | 41-113°F (5-45°C) | Same |
| Operating
Relative
Humidity | 10-90% | Same |
| Automatic
Shutoff | 120 seconds | Same |
| Power Source | Rechargeable 3.85V lithium ion
battery | Two CR 2032 3.0V coin cell batteries |
| Battery Charge
Time |