(121 days)
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.
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.
The Livongo Blood Glucose Monitoring System (BG1000) underwent extensive testing to establish its performance and demonstrate substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria for blood glucose monitoring systems typically align with ISO 15197 standards. While specific acceptance criteria are not explicitly enumerated with numerical targets for each performance metric in the provided text, the qualitative statements and the nature of the tests performed (precision, linearity, interference, user evaluation) imply adherence to recognized standards for accuracy and reliability in blood glucose measurement. The "Discussion of Substantial Equivalence" explicitly states that testing demonstrated the candidate device is substantially equivalent, which implies meeting performance benchmarks comparable to predicate devices and relevant standards.
To infer the implied acceptance criteria from the reported performance, we look for statements confirming the results were "within" acceptable ranges or demonstrated "accurate readings."
| Acceptance Criteria (Inferred from Performance Statements) | Reported Device Performance (Summary from provided K200277) |
|---|---|
| Precision: Glucose readings are consistent within acceptable ranges. | Within-Run Precision: SD or %CV values reported are low (e.g., 1.49 mg/dL to 2.33 mg/dL for lower concentrations, 2.5% to 2.7% for higher concentrations). Intermediate Precision: SD or %CV values reported are low (e.g., 1.41 mg/dL to 2.30 mg/dL for lower concentrations, 2.2% to 2.9% for higher concentrations). |
| Linearity: Device accurately measures glucose across its specified testing range. | Linear regression analysis results show high R² values (0.9968 to 0.9984) and slopes close to 1, with small y-intercepts. This "support[s] the glucose measurement range of 40-600 mg/dL." |
| Interference (Hematocrit): Glucose measurement is not significantly affected by varying hematocrit levels. | Bias of measurement was within ±10 mg/dL for glucose concentration level 1, and within ±8% for glucose concentration levels 2-6, with no individual value having a bias greater than 15%. This confirms "accurate readings for the specified hematocrit range of 10%-70%." |
| Robustness (Flex Studies): System maintains performance under various environmental and operational stresses. | "System operated within its specified operating ranges even under stress conditions, and errors were correctly displayed when outside the meter's operating ranges." This includes mechanical vibration and shock, operating conditions (temperature/humidity), altitude, stability, samples outside range, short sample detection, sample perturbation, intermittent sampling, and used strips. |
| Electromagnetic Interference (EMI) & Electrical Safety: Device complies with relevant safety and EMI standards. | 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." Also passed EMC testing to "IEC 60601-1-2, FCC 47 CFR 15 Part B, and PTCRB." |
| Software: Software functionality meets design requirements and safety standards. | "Testing and documentation for Moderate level of concern software was completed" per FDA guidance. |
| Clinical Performance (User Evaluation): Lay users can operate the device accurately and are satisfied with ease of use. | Study results indicated that "non-professional, inexperienced lay persons were able to obtain blood glucose readings... comparable to the comparator YSI 2300 obtained by trained technicians." Furthermore, "participating lay persons were questioned and responded as satisfied with the ease of operation... and the overall performance." |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Evaluation (Within-Run & Intermediate):
- Sample Size: Ten replicate assays were run on ten Livongo meters using three strip lots for each of six glucose concentration levels.
- Data Provenance: The study used "heparinized venous blood samples." The document does not specify the country of origin, but it is a non-clinical/laboratory study.
- Linearity Evaluation:
- Sample Size: Blood samples were prepared at eleven glucose concentration levels and run on 10 meters using test strips from three lots.
- Data Provenance: The document does not specify the country of origin. It is a non-clinical/laboratory study using prepared blood samples.
- Interference – Hematocrit:
- Sample Size: Whole blood samples were prepared to hematocrit levels across the claimed range at 5% intervals with six glucose concentration levels. Test strips from three lots were used.
- Data Provenance: The document does not specify the country of origin. It is a non-clinical/laboratory study using prepared blood samples.
- Clinical (User Evaluation) Study:
- Sample Size: Not explicitly stated but implied to be a cohort of "lay persons."
- Data Provenance: "Simulated home environment." The document does not specify the country of origin or whether it was retrospective or prospective, but a "user evaluation" implies a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- All Non-Clinical Studies (Precision, Linearity, Hematocrit): The ground truth was established by a "YSI (Model 2300 STAT PLUS) Glucose Analyzer reference instrument, which is traceable to NIST reference standard." This is an analytical reference method, not human experts.
- Clinical (User Evaluation) Study: The ground truth for comparative blood glucose readings was obtained by "trained technicians" using the YSI 2300 Stat Plus Glucose Analyzer. The number and specific qualifications of these technicians are not provided.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. The ground truth was established by a reference analytical instrument or trained technicians using a reference instrument, not by expert consensus requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The clinical study was a user evaluation demonstrating the ability of lay persons to use the device accurately, not a comparative study of human readers with vs. without AI assistance. The device itself is a standalone measurement system, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
Yes, the device's performance in the non-clinical studies (precision, linearity, interference, flex studies) directly demonstrates its standalone (algorithm only) performance when measuring glucose. The "user evaluation" study then assessed the ability of lay users to successfully operate this standalone system.
7. Type of Ground Truth Used
- Non-Clinical Studies (Precision, Linearity, Hematocrit): The ground truth was established using an analytical reference instrument, specifically the "YSI (Model 2300 STAT PLUS) Glucose Analyzer," which is traceable to the NIST reference standard.
- Clinical (User Evaluation) Study: The ground truth was established by trained technicians using the "YSI 2300 Stat Plus Glucose Analyzer."
8. Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI. This device is a blood glucose meter, and its performance is typically evaluated through analytical and clinical validation studies, not by training a machine learning model on a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned in the context of this device.
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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 (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
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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: +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.
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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).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 diagnosticuse and is not intended for thediagnosis of or screening for diabetes,nor intended for use on neonates. | Systems are intended for single-patient useand should not be shared. | |
| The On Call Sure and On Call Sure SyncBlood Glucose Monitoring Systems are forin vitro diagnostic use. The On Call Sure andOn Call Sure Sync Blood GlucoseMonitoring Systems are not intended forthe diagnosis of or screening for diabetes,nor intended for use on neonates.Alternative site testing should be done onlyduring steady-state times (when glucose isnot changing rapidly). | ||
| DetectionMethod | Amperometric electrochemical | Same |
| Enzyme | Glucose Dehydrogenase (FAD-GDH) | Same |
| CalibrationCoding | Auto-coding | Same |
| Test Range | 40 - 600 mg/dL | Same |
| Units ofMeasurement | mg/dL | Same |
| ResultCalibration | Plasma-equivalent, calibrated by usingYSI (Model 2300 STAT PLUS) GlucoseAnalyzer reference instrument, whichis traceable to NIST referencestandard. | 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 TestTime | 5 seconds | Same |
| HematocritRange | 10 - 70% | Same |
| Altitude Study | Up to 10000 feet | Same |
| OperatingTemperature | 41-113°F (5-45°C) | Same |
| OperatingRelativeHumidity | 10-90% | Same |
| AutomaticShutoff | 120 seconds | Same |
| Power Source | Rechargeable 3.85V lithium ionbattery | Two CR 2032 3.0V coin cell batteries |
| Battery ChargeTime | <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 ScreenSize | 4" | 2.25" |
| Meter UserInterface | Touch-panel LCM | Monochrome display with push buttoninterface |
| Camera | Yes (hardware support only) | No |
| Speaker | Yes | Same |
| Microphone | Yes (hardware support only) | No |
| Strip light | 1 | 0 |
| 3-axisaccelerometer | 1 (hardware support only) | 0 |
| Vibrator motor | Yes (hardware support only) | No |
| Electrical SafetyTesting | IEC 61010 compliant | Same |
| EMC Testing | IEC 60601-1-2 compliant | Same |
| MethodComparison/User Evaluation | Per FDA guidance "Self-MonitoringBlood Glucose Test Systems for Over-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).
§ 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.