(760 days)
No reference device was used in this submission.
No
The summary describes a standard blood glucose monitoring system using amperometric detection and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) device used to monitor glucose levels, not to treat a condition. It provides information to aid in diabetes control but does not directly provide therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for neonatal use or for the diagnosis of or screening for diabetes." It is meant for "monitoring the effectiveness of diabetes control," not for diagnosis.
No
The device description explicitly states that the system consists of a blood glucose meter (hardware) and test strips (hardware), in addition to software validation being performed.
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)".
Furthermore, the device description details how the system measures glucose concentration in a blood sample using a chemical reaction on a test strip, which is a characteristic of in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
VivaChek™ Fad 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™ Fad 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™ Fad 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.
Product codes
NBW
Device Description
VivaChek™ Fad Blood Glucose Monitoring System consists of VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.
VivaChek™ Fad Smart Blood Glucose Monitoring System consists of VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.
VivaChek™ Fad Sync Blood Glucose Monitoring System consists of VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.
VivaChek Fad Control Solution, VivaChek Lancing Device, VivaChek Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The VivaChek Fad Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. VivaChek Lancing Device and VivaChek Lancets are used for puncturing fingertip and then user can perform glucose test with blood sample.
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System are designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. 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 dehydrogenase 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.
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 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)
Studies and testing activities included cleaning and disinfection, robustness, precision, linearity, user evaluation, usability evaluation, interference, flex studies including electrical safety test and electromagnetic compatibility test, software validation. Test data and results from laboratory studies showed that these devices performed as intended and met associated guidance documents and industry standards.
Clinical studies (user evaluations) were conducted with intended users using the VivaChek™ Fad Blood Glucose Monitoring System and VivaChek™ Fad Smart Blood Glucose Monitoring System. Usability evaluation was performed on VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, and VivaChek™ Fad Sync Blood Glucose Monitoring System respectively.
Studies result indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the VivaChek™ Fad Blood Glucose Monitoring System and VivaChek™ Fad Smart Blood Glucose Monitoring System. The clinical studies data showed that the clinical performance met the FDA SMBG OTC Guidance. All participants had the ability of understanding of the labeling, could use of systems and could interpret the testing results and error messages based on the usability evaluation reports. There was no adverse effect or complication occurred or identified during the clinical studies including usability evaluations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference device was used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 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" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Vivachek Biotech (Hangzhou) Co., Ltd Mark Qian Quality Director Level 2, Block 2, 146 East Chaofeng Road Yuhang Econimic Development Zone Hangzhou, 311100, Zhejiang, China
Re: K222126
Trade/Device Name: VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: July 21, 2023 Received: July 21, 2023
Dear Mark Qian:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
August 16, 2024
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K222126
Device Name
VivaChek™ Fad Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Fad Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips.
VivaChek™ Fad 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K222126
Device Name
VivaChek™ Fad Smart Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Fad Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips.
VivaChek™ Fad 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.
| 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K222126
Device Name
VivaChek™ Fad Sync Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Fad Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips.
VivaChek™ Fad 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
The Assigned 510(k) number is K222126.
1. Submitter's Information
1.1 Submitter's Name, Address and Telephone Number
Name: VivaChek Biotech (Hangzhou) Co., Ltd
Address: Level 2, Block 2, 146 East Chaofeng Rd.,
Yuhang Economy Development Zone,
Hangzhou, 311100, Zhejiang, China.
Telephone: +86 571 8918 9521
1.2 Contact Person
Name: Mark Qian Position: Quality Director Email: mark.qian@vivachekbio.com
1.3 Date Updated for Summary
Aug 12, 2024
2. Devices Name
2.1 Proprietary Name:
VivaChek™ Fad Blood Glucose Monitoring System VivaChek™ Fad Smart Blood Glucose Monitoring System VivaChek™ Fad Sync Blood Glucose Monitoring System
2.2 Common Name
Glucose Test System
2.3 Classification Name
Classification Name: Glucose Test System Regulation Number: 21 CFR 862.1345 Requlatory Class: Class II
6
Product Code: NBW
2.4 Predicate (Legally Marketed) Device
Predicate Name: TD-4183 Blood Glucose Monitoring System.
510(k) Number: K190579.
Applicant: TaiDoc Technology Corporation.
No reference device was used in this submission.
3. Devices Description
VivaChek™ Fad Blood Glucose Monitoring System consists of VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.
VivaChek™ Fad Smart Blood Glucose Monitoring System consists of VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.
VivaChek™ Fad Sync Blood Glucose Monitoring System consists of VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.
VivaChek Fad Control Solution, VivaChek Lancing Device, VivaChek Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The VivaChek Fad Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. VivaChek Lancing Device and VivaChek Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System are designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The ducose 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 dehydrogenase 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.
4. Intended Use:
VivaChek™ Fad Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose
7
VivaChek Biotech (Hangzhou) Co., Ltd Address: Level 2. Block 2. 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang, China Contact: Mark Qian Email: mark.gian@vivachekbio.com Tel: +86 571 8918 9521
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™ Fad Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. VivaChek™ Fad 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™ Fad Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. VivaChek™ Fad 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.
8
5. Comparison of Technological Characteristics with Predicate Device:
5.1 Comparison of VivaChek™ Fad Blood Glucose Monitoring System with the predicate.
| Characteristics | Predicate: TD-4183 Blood Glucose Monitoring System (K190579) | Candidate: VivaChek™ Fad Blood Glucose Monitoring System | Characteristics | Predicate: TD-4183 Blood Glucose
Monitoring System (K190579) | Candidate:
VivaChek™ Fad
Smart Blood Glucose
Monitoring System | Candidate:
VivaChek™ Fad Sync
Blood Glucose
Monitoring System |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------|
| Similarities | | | | Similarities | | |
| Intended Use | It is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. | Same | Intended Use | It is intended for use in the quantitative
measurement of glucose in fresh
capillary whole blood from the
fingertip. This system is intended for
self-testing outside the body (in vitro
diagnostic use) by people with
diabetes mellitus at home as an aid in
monitoring the effectiveness of the
diabetes control program. It is
intended to be used by single person
and should not be shared. It is not
intended for the diagnosis of or
screening for diabetes mellitus, and is
not intended for use on neonates. | Same | Same |
| Work (Operation) Principle | Electrochemical biosensor technology | Same | Work (Operation)
Principle | Electrochemical biosensor technology | Same | Same |
| Detection Method | Amperometry | Same | Detection Method | Amperometry | Same | Same |
| Strip Chemical Composition | Glucose Dehydrogenase -FAD | Same | Strip Chemical
Composition | Glucose Dehydrogenase -FAD | Same | Same |
| Test Measured | Glucose in fingertip capillary whole blood | Same | Test Measured | Glucose in fingertip capillary blood | Same | Same |
| Sample Type | Fresh capillary whole blood | Same | Sample Type | Fresh capillary whole blood | Same | Same |
| Unit of Measurement | mg/dL | Same | Unit of
Measurement | mg/dL | Same | Same |
| Operating Relative Humidity | 10-90% | Same | Operating
Relative Humidity | 10-90% | Same | Same |
| Differences | | | | Differences | | |
| Measurement Range | 20 to 650 mg/dL | 20 to 600 mg/dL | Measurement
Range | 20 to 650 mg/dL | 20 to 600 mg/dL | 20 to 600 mg/dL |
| Test Time | 6 seconds | 5 seconds | Test Time | 6 seconds | 5 seconds | 5 seconds |
| Sample Size | 0.5µL | 0.8µL | Sample Size | 0.5µL | 0.8µL | 0.8µL |
| Hematocrit Range | 20-65% | 20-70% | Hematocrit Range | 20-65% | 20-70% | 20-70% |
| Strips Storage | 35.6-86°F, 10-85% RH | 36-86°F, 10-90% RH | Strips Storage | 35.6-86°F, 10-85% RH | 36-86°F, 10-90% RH | 36-86°F, 10-90% RH |
| Power Source | 1 x 1.5V AAA battery | One (1) CR 2032 3.0V coin cell battery | Power Source | 1 x 1.5V AAA battery | Rechargeable,
250mAh, 3.7 volts,
lithium polymer
battery | Rechargeable,
250mAh, 3.7 volts,
lithium polymer
battery |
9
5.2 Comparison of VivaChek™ Fad Smart Blood Glucose Monitoring System and
10
6. Laboratory (Nonclinical) and Clinical Studies
6.1 Studies/Tests with Performance Data
Studies and testing activities included cleaning and disinfection, robustness, precision, linearity, user evaluation, usability evaluation, interference, flex studies including electrical safety test and electromagnetic compatibility test, software validation. The following laboratory and clinical studies with performance data were provided in the submission to support of the substantial equivalence determination.
| No. | Study/Test Item |
|---|---|
| 1 | Cleaning and Disinfection Study |
| 2 | Meter Robustness Study |
| 3 | Within-Run Precision Evaluation |
| 4 | Intermediate Precision Evaluation |
| 5 | Linearity Evaluation Study |
| 6 | User Evaluations |
| 7 | Usability Evaluations |
| 8 | Interference Agents Study |
| 9 | Hematocrit Effect Study |
| 10 | Accelerated Closed Vial Stability Studies |
| 11 | Accelerated Open Vial Stability Studies |
| 12 | Real Time Closed Vial Stability Studies |
| 13 | Real Time Open Vial Stability Studies |
| 14 | Sample Perturbation Study |
| 15 | Short Sample Detection Study |
| 16 | Low Battery Study |
| 17 | Altitude Effect Evaluation |
| 18 | Operating Conditions Evaluation |
| 19 | Intermittent Sampling Study |
| 20 | Vibration Test, Shock Test |
| 21 | Meter Environmental Temperature Test |
| 22 | Error Message Test |
| 23 | Testing with Used Test Strips |
| 24 | Test Strip Early Removal Validation |
| 25 | Incorrect Strip Insertion Validation |
| 26 | Recharging Temperature Limit Validation |
| 27 | FCC Tests |
| 28 | Electrical Safety Test |
| 29 | Electromagnetic Compatibility Test |
| 30 | Meter Software Documentation etc. |
11
VivaChek Biotech (Hangzhou) Co., Ltd
Address: Level 2. Block 2. 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang, China Contact: Mark Qian Email: mark.gian@vivachekbio.com Tel: +86 571 8918 9521
6.2 Brief Discussion of Laboratory (Nonclinical) Studies:
Laboratory (nonclinical) studies were performed on the VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System in accordance with the FDA SMBG OTC Guidance, CLSI quidelines and industry standards. Test data and results from laboratory studies showed that these devices performed as intended and met associated guidance documents and industry standards.
6.3 Brief Discussion of Clinical Studies including Usability Evaluations:
Since the VivaChek™ Fad Sync Blood Glucose Monitoring System has the same intended use, work principle and technological characteristics as VivaChek™ Fad Smart Blood Glucose Monitoring System, clinical studies (user evaluations) were conducted with intended users using the VivaChek™ Fad Blood Glucose Monitoring System and VivaChek™ Fad Smart Blood Glucose Monitoring System. Usability evaluation was performed on VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, and VivaChek™ Fad Svnc Blood Glucose Monitoring System respectively.
Studies result indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the VivaChek™ Fad Blood Glucose Monitoring System and VivaChek™ Fad Smart Blood Glucose Monitoring System. The clinical studies data showed that the clinical performance met the FDA SMBG OTC Guidance. And all participants had the ability of understanding of the labeling, could use of systems and could interpret the testing results and error messages based on the usability evaluation reports. In addition, there was no adverse effect or complication occurred or identified during the clinical studies including usability evaluations. Therefore, these studies support the intended use as described in the proposed labeling.
12
7. Conclusion:
The nonclinical studies and clinical studies results demonstrate that the VivaChek™ Fad Blood Glucose Monitoring System and VivaChek™ Fad Smart Blood Glucose Monitoring System performed as intended and met FDA SMBG OTC Guidance and industry standards. The different characteristics listed in Section 5 of this summary do not raise safety and effectiveness questions according to the completed and accepted nonclinical and clinical studies. VivaChek™ Fad Blood Glucose Monitoring System and VivaChek™ Fad Smart Blood Glucose Monitoring System are as safe, as effective and perform better than the predicate device.
As described in the Section 6.3 above, VivaChek™ Fad Sync Blood Glucose Monitoring System has the same intended use, work principle and technological characteristics as VivaChek™ Fad Smart Blood Glucose Monitoring System, and based on the laboratory studies results, the user evaluation result from VivaChek™ Fad Smart Blood Glucose Monitoring System, and usability evaluation for VivaChek™ Fad Sync Blood Glucose Monitoring System. VivaChek™ Fad Sync Blood Glucose Monitoring System is also as safe, as effective and performs better than the predicate device.
Therefore, VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, and VivaChek™ Fad Sync Blood Glucose Monitoring System are substantially equivalent to the predicate device.