(446 days)
Not Found
No
The document describes a standard blood glucose monitoring system using amperometric detection. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is a direct chemical reaction measurement.
No.
This device is an in-vitro diagnostic device used to measure glucose levels, not to provide therapeutic treatment.
No.
The device is explicitly stated as "not intended for neonatal use or for the diagnosis of or diabetes." It is instead intended as "an aid to monitor the effectiveness of diabetes control," which is a management function rather than a diagnostic one.
No
The device is described as a "Blood Glucose Monitoring System" comprised of a "Blood Glucose Meter" and "Blood Glucose Test Strips". The description details the hardware components and the electrochemical method used to measure glucose, indicating it is a hardware-based device with associated software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "This system is intended for self-testing outside the body (in vitro diagnostic use)". This phrase directly indicates that the device is designed for testing biological samples (blood) outside of the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sync Blood Glucose Meter (VGM05) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Simple Blood Glucose Meter (VGM26) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Bright Blood Glucose Meter (VGM27) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model:VGM09), VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26), VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) are designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04), VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09) and VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22) contain Bluetooth, the devices comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability.
VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26)and VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) contain talking functionality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip capillary blood.
Indicated Patient Age Range
Not intended for neonatal use.
Intended User / Care Setting
Persons with diabetes at home for self-testing.
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)
Laboratory Testing:
The performance characteristics of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems were evaluated by performing the following studies:
- Linearity Study: Pass (Reference: FDA SMBG Guidance)
- User Evaluation: Pass (Reference: FDA SMBG Guidance)
- User Evaluation-Accuracy at Extreme Glucose Values: Pass (Reference: FDA SMBG Guidance)
- Accelerated Closed vial Stability Study_Strip with 65°C: Pass (Reference: FDA SMBG Guidance)
- Real Time Open Vial stability Study_Strip: In-process (Reference: FDA SMBG Guidance, ISO 23640)
- Real Time Extended Open Vial stability Study_Strip: Pass (Reference: FDA SMBG Guidance)
- Sample Perturbation Study: Pass (Reference: FDA SMBG Guidance, ISO15197:2015)
- Accelerated Closed vial Stability Study_Control with 65°C: Pass (Reference: FDA SMBG Guidance)
- Real Time Open Vial stability Study _Control: Pass (Reference: FDA SMBG Guidance)
- Real Time Extend Open Vial stability Study_Control: Pass (Reference: FDA SMBG Guidance)
- Hematocrit Effect Study: Pass (Reference: FDA SMBG Guidance)
- Sample Volume Study: Pass (Reference: FDA SMBG Guidance)
- Intermediate Precision Study: Pass (Reference: FDA SMBG Guidance)
- Within-Run Precision Study: Pass (Reference: FDA SMBG Guidance)
- Low Battery Study: Pass (Reference: FDA SMBG Guidance)
- Altitude Effect Evaluation: Pass (Reference: FDA SMBG Guidance)
- Operating Conditions Evaluation: Pass (Reference: FDA SMBG Guidance)
- Shipping Study _test strip: Pass (Reference: FDA SMBG Guidance)
- Shipping Study_Control: Pass (Reference: FDA SMBG Guidance)
- Control Range Assignment: Pass (Reference: FDA SMBG Guidance)
- Oxygen Interference Study: Pass (Reference: FDA SMBG Guidance)
- Intermittent Sampling Study: Pass (Reference: FDA SMBG Guidance)
- Interference Agents Study: Pass (Reference: FDA SMBG Guidance, ISO15197:2015)
- Real Time Closed Vial Stability Study _Strip Study: In-process (Reference: FDA SMBG Guidance, ISO 23640)
- Real Time Closed Vial Stability Study _Control Study: Pass (Reference: FDA SMBG Guidance)
- Meter Robustness Study: Pass (Reference: FDA SMBG Guidance)
- Meter Vibration Test: Pass (Reference: FDA SMBG Guidance)
- Meter Shock Test: Pass (Reference: FDA SMBG Guidance)
- Meter Environmental Temperature Test: Pass (Reference: FDA SMBG Guidance)
- Meter Bluetooth Communication Distance Test: Pass (Reference: Design Specification & FCC Rule Part 15 Subpart C (Section 15.247))
- Meter Talking Features (Functionality) Test: Pass (Reference: Design specification)
- Error Codes Test: Pass (Reference: Design specification)
- Testing with Used Test Strips: Pass (Reference: Design specification)
- Meter Software Documentation: Pass (Reference: Guidance for the Content of Premarket Submission for Software Contained in Medical Devices)
- GlucoWell App Software Documentation: Pass (Reference: Guidance for the Content of Premarket Submission for Software Contained in Medical Devices)
- Electromagnetic Compatibility and Electrical and Safety: Pass (Reference: IEC 60601-1- 2; IEC 60601-1; IEC 60601-1-11)
- Cybersecurity (for VGM04, 05, 09, 22): Pass (Reference: Cybersecurity for Networked Medical Devices Containing OTS Software: Content of Premarket Submission for Management of Cybersecurity in Medical Devices)
Clinical Study (User Evaluation):
Clinical (user evaluation) studies were conducted with intended user, lay persons using the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems. The study data were presented evaluating the system accuracy of these systems per their respective VivaChek User Evaluation Study Protocols.
Key Results: Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the systems. Additionally, participated lay persons were satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the systems.
The VivaChek™ Ino Sync (VGM05) and VivaChek™ Ino Sound Bright (VGM27) have the same intended use, fundamental scientific technology and performance characteristics as VivaChek™ Ino Smart (VGM04) and VivaChek™ Ino Sound Simple (VGM26) respectively, demonstrating equivalent safety, effectiveness, and 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.
Not Found
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.
0
Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
December 19, 2018
VivaChek Laboratories, Inc. Julie Zhou Manager of Regulatory Affair Department 913 N Market Street, Suite 200 Wilmington, DE 19081
Received: November 16, 2018
Re: K173140
Trade/Device Name: VivaChek Ino Smart Blood Glucose Monitoring System VivaChek Ino Sync Blood Glucose Monitoring System VivaChek Ino Sound Blood Glucose Monitoring System VivaChek Ino Plus Blood Glucose Monitoring System VivaChek Ino Sound Simple Blood Glucose Monitoring System VivaChek Ino Sound Bright Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 8, 2018
Dear Julie Zhou:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K173140
Device Name
VivaChek™ Ino Smart Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K173140
Device Name
VivaChek™ Ino Sync Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sync Blood Glucose Meter (VGM05) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K173140
Device Name
VivaChek™ Ino Sound Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K173140
Device Name
VivaChek™ Ino Plus Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™M Ino Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K173140
Device Name
VivaChek™ Ino Sound Simple Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Simple Blood Glucose Meter (VGM26) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K173140
Device Name
VivaChek™ Ino Sound Bright Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Bright Blood Glucose Meter (VGM27) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
Section T8
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.
The Assigned 510(k) number is K173140
Submitter's Identification:
VivaChek Laboratories, Inc. 913 N Market Street, Wilmington, DE, 19801, USA
Tel/Fax.: 302-339-8107
Date Updated: Dec 18, 2018
Contact Person:
Julie Zhou Regulatory Affairs Manager VivaChek Laboratories. Inc. 913 N Market Street, Wilmington, DE, 19801, USA
Proprietary Name of the Device:
VivaChek™ Ino Smart Blood Glucose Monitoring System VivaChek™ Ino Sync Blood Glucose Monitoring System VivaChek™ Ino Sound Blood Glucose Monitoring System VivaChek™ Ino Plus Blood Glucose Monitoring System VivaChek™ Ino Sound Simple Blood Glucose Monitoring System VivaChek™ Ino Sound Bright Blood Glucose Monitoring System
Common Name: Glucose Test System
Classification Name:
Class II §862.1345 Glucose Test System Product code: NBW
Predicate Device:
VivaChek™ Ino Blood Glucose Monitoring System VivaChek Laboratories, Inc. 913 N Market Street, Wilmington, DE, 19801, USA 510(k) Number: K160179
9
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA
Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
Section T8
Device Name:
| Proprietary Name | Model
No. | Classification | Product
Code | Description | Common
Name |
|------------------------------------------------------------------|--------------|----------------------|-----------------|--------------------------------------------------|------------------------|
| VivaChek™ Ino Smart
Blood Glucose
Monitoring System | VGM04 | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
| VivaChek™ Ino Sync
Blood Glucose
Monitoring System | VGM05 | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
| VivaChek™ Ino Sound
Blood Glucose
Monitoring System | VGM09 | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
| VivaChek™ Ino Plus
Blood Glucose
Monitoring System | VGM22 | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
| VivaChek™ Ino Sound
Simple Blood Glucose
Monitoring System | VGM26 | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
| VivaChek™ Ino Sound
Bright Blood Glucose
Monitoring System | VGM27 | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
Description:
VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model:VGM09), VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26), VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) are designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The
10
Section T8
blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04), VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09) and VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22) contain Bluetooth, the devices comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Please refer to the FCC PART 15.247 BLE Test Reports #1803WSU007-U1 for VGM09 and VGM22 systems, and #1803WSU007-U2 for VGM04 and VGM05 systems.
VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26)and VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) contain talking functionality, refer to Talking Feature Validation Protocols and Reports, and Meter Robustness Study Protocol and Report.
Intended Use:
VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sync Blood Glucose Meter (VGM05) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the
11
Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
Section T8
body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Simple Blood Glucose Meter (VGM26) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Bright Blood Glucose Meter (VGM27) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for
12
Section T8
neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
Technological Characteristics:
Specification of VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04):
| Feature | Specification |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Test Measured | Glucose in fingertip capillary blood |
| Sample | Fresh capillary whole blood |
| Sample volume: | 0.8 µL |
| Test time | 5 seconds |
| Power source | Rechargeable 3.7 Volt Lithium Ion battery |
| Charging current | 100mAh, === Direct current |
| Battery type | Rechargeable, non-serviceable, 250mAh, 3.7 Volt DC nominal, lithium |
| polymer battery (5V input charge voltage) | |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
| Memory | Up to 500 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 83 mm x 52 mm x 18.7 mm |
| Display size | 32mm x 32 mm |
| Weight | Approximately 53g |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
| Data port | Micro USB |
| Bluetooth | Version 4.1 (syncing with a iPhone for data and time) |
Specification of VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05):
| Feature | Specification |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Test Measured | Glucose in fingertip capillary blood |
| Sample | Fresh capillary whole blood |
| Sample volume: | 0.8 µL |
| Test time | 5 seconds |
| Power source | Rechargeable 3.7 Volt Lithium Ion battery |
| Charging current | 100mAh, — Direct current |
| Battery type | Rechargeable, non-serviceable, 250mAh, 3.7 Volt DC nominal, lithium |
| polymer battery (5V input charge voltage) | |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
13
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
| Section T8 | |
|---|---|
| Memory | Up to 500 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 90.4 mm x 54.5 mm x 27.8 mm |
| Display size | 32mm x 32 mm |
| Weight | Approximately 53g |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
| Data port | Micro USB |
| Dimensions | 90.4 mm x 54.5 mm x 27.8 mm |
Specification of VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09):
| Feature | Specification |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Test Measured | Glucose in fingertip capillary blood |
| Sample | Fresh capillary whole blood |
| Sample volume: | 0.8 µL |
| Test time | 5 seconds |
| Power source | Two AAA LR03 1.5V batteries |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
| Memory | Up to 1000 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 90.4 mm x 54.5 mm x 27.8 mm |
| Display size | 39 mm x 41 mm |
| Weight | Approximately 63g |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
| Data port | Micro USB |
| Bluetooth | Version 4.1 (syncing with a iPhone for data and time) |
Specification of VivaChek™ Ino Plus Blood Glucose Monitoring System (Model: VGM22):
| Feature | Specification |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Test Measured | Glucose in fingertip capillary blood |
| Sample | Fresh capillary whole blood |
14
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA
Contact: Ms. Julie Zhou
Section T8
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
| Sample volume: | 0.8 μL |
|---|---|
| Test time | 5 seconds |
| Power source | Two AAA LR03 1.5V batteries |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
| Memory | Up to 1000 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 90.4 mm x 54.5 mm x 27.8 mm |
| Display size | 39 mm x 41 mm |
| Weight | Approximately 63g |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
| Data port | Micro USB |
| Bluetooth | Version 4.1 (syncing with a iPhone for data and time) |
Specification of VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26):
| Feature | Specification |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Test Measured | Glucose in fingertip capillary blood |
| Sample | Fresh capillary whole blood |
| Sample volume: | 0.8 µL |
| Test time | 5 seconds |
| Power source | Two AAA LR03 1.5V batteries |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
| Memory | Up to 1000 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 90.4 mm x 54.5 mm x 27.8 mm |
| Display size | 39 mm x 41 mm |
| Weight | Approximately 63g |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
Specification of VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27):
| Feature | Specification | |
|---|---|---|
| -- | --------- | --------------- |
15
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA Contact: Ms. Julie Zhou Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
| Section T8 | |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Test Measured | Glucose in fingertip capillary blood |
| Sample | Fresh capillary whole blood |
| Sample volume: | 0.8 μL |
| Test time | 5 seconds |
| Power source | Two AAA LR03 1.5V batteries |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
| Memory | Up to 1000 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 90.4 mm x 54.5 mm x 27.8 mm |
| Display size | 39 mm x 41 mm |
| Weight | Approximately 63g |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
Comparison to Predicate Devices:
The VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) is substantially equivalent to VivaChek™ Ino Blood Glucose Monitoring System (K160179)
| Features | VivaChek ™ Ino Blood Glucose
Monitoring System (K160179) | VivaChek ™ Ino Smart Blood Glucose
Monitoring System (Model: VGM04) |
|--------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------|
| | Similarities | |
| Assay Method | Glucose oxidase biosensor | Same |
| Measurement Range | 20 to 600 mg/dL | Same |
| Strip Chemical
Composition | Glucose oxidase, Mediator | Same |
| Test Measured | Glucose in fingertip capillary blood | Same |
| Test Time | 5 seconds | Same |
| Sample Type | Fresh capillary whole blood | Same |
| Glucose Units of
Measure | mg/dL | Same |
| Operating Relative
Humidity | 10-90% | Same |
| Data Port | mini USB | Same |
| Automatic Shutoff | 2 minutes after last action | Same |
| Minimum Sample Size | 0.8µL | Same |
16
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA
Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
Section T8
| Hematocrit Range | 20-70% | Same |
|---|---|---|
| Operating | ||
| Temperature | 5-45°C (41-113°F) | Same |
| Differences | ||
| Alternative Sample | ||
| Site for Capillary | Palm and forearm in addition to | |
| fingertip | None | |
| Meter Memory | Up to 900 records with time and date | Up to 500 records with time and date |
| Battery Life | 12 months or approximately 1,000 | |
| tests | Rechargeable | |
| Power Source | Two (2) CR 2032 3.0V coin cell | |
| batteries | Rechargeable, non-serviceable, 250mAh, | |
| 3.7 Volt DC nominal, lithium polymer | ||
| battery (5V input charge voltage) | ||
| Meter Size | 82.5 mm × 52 mm × 18.2 mm | 83 mm x 52 mm x 18.7 mm |
| Meter Weight | Approximately 47g (with battery | |
| installed) | Approximately 53g | |
| Bluetooth | None | Yes |
The other 5 subject devices (VGM05, VGM09, VGM26, VGM27) are substantially equivalent to VivaChek™ Ino Blood Glucose Monitoring System(K160179)
| Features | VivaChek™ Ino Blood Glucose
Monitoring System(K160179) | VGM04 | VGM05 | VGM09 | VGM22 | VGM26 | VGM27 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------|-------|-------|-------|
| Intended Use | It is intended to quantitatively
measure the glucose
concentration in fresh capillary
whole blood samples drawn from
the fingertips. It is intended for
use by persons with diabetes at
home as an aid to monitor the
effectiveness of diabetes control.
It is not intended for neonatal use
or for the diagnosis of or
screening for diabetes. This
system is intended for
self-testing outside the body (in
vitro diagnostic use), and should
only be used by a single person
and should not be shared | Same | Same | Same | Same | Same | Same |
| Assay Method | Glucose oxidase biosensor | Same | Same | Same | Same | Same | Same |
| Strip Chemical
Composition | Glucose oxidase, Mediator | Same | Same | Same | Same | Same | Same |
| Test measured | Glucose in fingertip capillary
whole blood | Same | Same | Same | Same | Same | Same |
| Measurement Range | 20 to 600 mq/dL | Same | Same | Same | Same | Same | Same |
| Test Time | 5 seconds | Same | Same | Same | Same | Same | Same |
| Sample Type | Fresh capillary whole blood | Same | Same | Same | Same | Same | Same |
| Glucose Units of
Measure | ma/dL | Same | Same | Same | Same | Same | Same |
| Operating Relative
Humidity | 10-90% | Same | Same | Same | Same | Same | Same |
| Data Port | mini USB | Same | Same | Same | Same | Same | Same |
| Automatic Shutoff | 2 minutes after last action | Same | Same | Same | Same | Same | Same |
| Minimum Sample Size | 0.8uL | Same | Same | Same | Same | Same | Same |
| Hematocrit Range | 20-70% | Same | Same | Same | Same | Same | Same |
| Operating Temperature | 5-45°C (41-113°F) | Same | Same | Same | Same | Same | Same |
| Alternative Sample Site | Palm and forearm in addition to | None | None | None | None | None | None |
17
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA
Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
| Section | T8 |
|---|
| for Capillary | fingertip | ||||||
|---|---|---|---|---|---|---|---|
| Meter Memory | Up to 900 records with time and | ||||||
| date | Up to 500 | ||||||
| records | |||||||
| with time | |||||||
| and date | Up to 500 | ||||||
| records | |||||||
| with time | |||||||
| and date | Up to 1000 | ||||||
| records | |||||||
| with time | |||||||
| and date | Up to 1000 | ||||||
| records | |||||||
| with time | |||||||
| and date | Up to 1000 | ||||||
| records | |||||||
| with time | |||||||
| and date | Up to 1000 | ||||||
| records | |||||||
| with time | |||||||
| and date | |||||||
| Battery Life | 12 months or approximately | ||||||
| 1,000 tests | Rechargea | ||||||
| ble | Rechargea | ||||||
| ble | Same | Same | Same | Same | |||
| Power Source | Two (2) CR 2032 3.0V coin cell | ||||||
| batteries | Rechargeable, | ||||||
| non-service | |||||||
| able, | |||||||
| 250mAh, | |||||||
| 3.7 Volt DC | |||||||
| nominal, | |||||||
| lithium | |||||||
| polymer | |||||||
| battery (5V | |||||||
| input charge | |||||||
| voltage) | Rechargeable, | ||||||
| non-service | |||||||
| able, | |||||||
| 250mAh, | |||||||
| 3.7 Volt DC | |||||||
| nominal, | |||||||
| lithium | |||||||
| polymer | |||||||
| battery (5V | |||||||
| input charge | |||||||
| voltage) | Two AAA | ||||||
| LR03 1.5V | |||||||
| batteries | Two AAA | ||||||
| LR03 1.5V | |||||||
| batteries | Two AAA | ||||||
| LR03 1.5V | |||||||
| batteries | Two AAA | ||||||
| LR03 1.5V | |||||||
| batteries | |||||||
| Meter Size | 82.5 mm × 52 mm × 18.2 mm | 83 mm x 52 | |||||
| mm x 18.7 | |||||||
| mm | 82 mm x 54 mm x 23 mm | 90.4 mm x | |||||
| 54.5 mm x | |||||||
| 27.8 mm | 90.4 mm x | ||||||
| 54.5 mm x | |||||||
| 27.8 mm | 90.4 mm x | ||||||
| 54.5 mm x | |||||||
| 27.8 mm | 90.4 mm x | ||||||
| 54.5 mm x | |||||||
| 27.8 mm | |||||||
| Meter Weight | Approximately 47g (with battery | ||||||
| installed) | Approximat | ||||||
| ely 53g | Approximat | ||||||
| ely 53g | Approximat | ||||||
| ely 63g | Approximat | ||||||
| ely 63g | Approximat | ||||||
| ely 63g | Approximat | ||||||
| ely 63g | |||||||
| Bluetooth | None | Yes | Yes | Yes | Yes | None | None |
| Talking function | None | None | None | Yes | None | Yes | Yes |
Laboratory Testing:
The performance characteristics of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems were evaluated by performing the following studies as below:
| No. | Test/Validation Item | Reference | Conclusion |
|---|---|---|---|
| 1 | Linearity Study | FDA SMBG Guidance | Pass |
| 2 | User Evaluation | FDA SMBG Guidance | Pass |
| 3 | User Evaluation-Accuracy at Extreme Glucose | ||
| Values | FDA SMBG Guidance | Pass | |
| 4 | Accelerated Closed vial Stability Study_Strip | ||
| with 65°C | FDA SMBG Guidance | Pass | |
| 5 | Real Time Open Vial stability Study_Strip | FDA SMBG Guidance | |
| ISO 23640 | In-process | ||
| 6 | Real Time Extended Open Vial stability | ||
| Study_Strip | FDA SMBG Guidance | Pass | |
| 7 | Sample Perturbation Study | FDA SMBG Guidance | |
| ISO15197:2015 | Pass | ||
| 8 | Accelerated Closed vial Stability Study | ||
| _Control with 65°C | FDA SMBG Guidance | Pass | |
| Section T8 | |||
| 9 | Real Time Open Vial stability Study _Control | FDA SMBG Guidance | Pass |
| 10 | Real Time Extend Open Vial stability Study | ||
| _Control | FDA SMBG Guidance | Pass | |
| 11 | Hematocrit Effect Study | FDA SMBG Guidance | Pass |
| 12 | Sample Volume Study | FDA SMBG Guidance | Pass |
| 13 | Intermediate Precision Study | FDA SMBG Guidance | Pass |
| 14 | Within-Run Precision Study | FDA SMBG Guidance | Pass |
| 15 | Low Battery Study | FDA SMBG Guidance | Pass |
| 16 | Altitude Effect Evaluation | FDA SMBG Guidance | Pass |
| 17 | Operating Conditions Evaluation | FDA SMBG Guidance | Pass |
| 18 | Shipping Study _test strip | FDA SMBG Guidance | Pass |
| 19 | Shipping Study_Control | FDA SMBG Guidance | Pass |
| 20 | Control Range Assignment | FDA SMBG Guidance | Pass |
| 21 | Oxygen Interference Study | FDA SMBG Guidance | Pass |
| 22 | Intermittent Sampling Study | FDA SMBG Guidance | Pass |
| 23 | Interference Agents Study | FDA SMBG Guidance | |
| ISO15197:2015 | Pass | ||
| 24 | Real Time Closed Vial Stability Study _Strip | ||
| Study | FDA SMBG Guidance | ||
| ISO 23640 | In-process | ||
| 25 | Real Time Closed Vial Stability Study _Control | ||
| Study | FDA SMBG Guidance | Pass | |
| 26 | Meter Robustness Study | FDA SMBG Guidance | Pass |
| 27 | Meter Vibration Test | FDA SMBG Guidance | Pass |
| 28 | Meter Shock Test | FDA SMBG Guidance | Pass |
| 29 | Meter Environmental Temperature Test | FDA SMBG Guidance | Pass |
| 30 | Meter Bluetooth Communication Distance Test | Design Specification & | |
| FCC Rule Part 15 Subpart | |||
| C (Section 15.247) | Pass | ||
| 31 | Meter Talking Features (Functionality) Test | Design specification | Pass |
| 32 | Error Codes Test | Design specification | Pass |
| Section T8 | |||
| 33 | Testing with Used Test Strips | Design specification | Pass |
| 34 | Meter Software Documentation | Guidance for the Content of | |
| Premarket Submission for | |||
| Software Contained in | |||
| Medical Devices | Pass | ||
| 35 | GlucoWell App Software Documentation | Guidance for the Content of | |
| Premarket Submission for | |||
| Software Contained in | |||
| Medical Devices | Pass | ||
| 36 | Electromagnetic Compatibility and Electrical and | ||
| Safety | IEC 60601-1- 2; | ||
| IEC 60601-1; | |||
| IEC 60601-1-11 | Pass | ||
| 37 | Cybersecurity (for VGM04, 05, 09, 22) | Cybersecurity for | |
| Networked Medical | |||
| Devices Containing OTS | |||
| Software: | |||
| Content of Premarket | |||
| Submission for | |||
| Management of | |||
| Cybersecurity in Medical | |||
| Devices | Pass |
18
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA
Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
19
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA
Contact: Ms. Julie Zhou
Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107
To confirm bluetooth and talking functionalities have not brought any unexpected functional failure or adverse effect, validation on these functionalities were also conducted, accepted and summarized in above table.
Discussion of Clinical Study:
Clinical (user evaluation) studies were conducted with intended user, lay persons using the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems. The study data were presented evaluating the system accuracy of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems per the VivaChek User Evaluation Study Protocols for these Blood Glucose Monitoring Systems. Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino
20
Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems.
The VivaChek™ Ino Sync (VGM05) has the same intended use, fundamental scientific technology and performance characteristics as VivaChek™ Ino Smart (VGM04). Therefore, the safety, effectiveness and performance are same as the predicate device.
The VivaChek™ Ino Sound Bright (VGM27) has the same intended use, fundamental scientific technology and performance characteristics as VivaChek™ Ino Sound Simple (VGM26). Therefore, the safety, effectiveness and performance are same as the predicate device.
Conclusion:
Section T8
The laboratory testing and user evaluation study results demonstrate that the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple(VGM26) Blood Glucose Monitoring System are safe, effective and easy-to-use. It also demonstrates that the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Smart Glucose Monitoring Systems meet FDA SMBG Guidance and are substantially equivalent to the VivaChek™ Ino Blood Glucose Monitoring System (K160179). Based on same intended use and technology characteristics, and the test results on user friendly functionalities on bluetooth or talking, the other two subject devices (VGM05, VGM27) are also substantially equivalent to the predicate device.