VivaChek Link Plus Blood Glucose Monitoring System

K233058 · Vivachek Biotech (Hangzhou) Co., Ltd. · NBW · Dec 22, 2023 · Clinical Chemistry

Device Facts

• Record ID: K233058
• Device Name: VivaChek Link Plus Blood Glucose Monitoring System
• Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. VivaChek™ Link 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.

Device Story

System uses electrochemical amperometric biosensor to measure glucose concentration in fresh capillary whole blood. Blood sample drawn into test strip via capillary action; glucose reacts with glucose oxidase and mediator to generate electrons; resulting current correlates to glucose concentration. Device includes 4G module for data transmission. Used by patients with diabetes at home for self-monitoring. Output displayed on meter screen; helps patients track glucose levels to manage diabetes. Device is handheld, battery-operated, and intended for single-patient use.

Clinical Evidence

Lay user study (n=352) demonstrated 100% of results within ±20% of comparator (YSI 2300) across 48.1–314.5 mg/dL range. Accuracy at extreme glucose concentrations (n=105) showed 100% within ±20% for both <80 mg/dL and >250 mg/dL ranges. Bench testing validated precision, linearity, interference, hematocrit (20-70%), altitude (up to 10,413 ft), and environmental operating conditions.

Technological Characteristics

Electrochemical amperometric biosensor; glucose oxidase chemistry. Rechargeable 3.7V lithium polymer battery. 4G wireless connectivity. Dimensions: 100.9mm x 61.6mm x 23.7mm. Weight: ~85g. Operating range: 20-600 mg/dL; 20-70% hematocrit; 41-113°F. Complies with FCC Part 15, 2, 24, 27, and 47 CFR § 2.1093.

Indications for Use

Indicated for persons with diabetes for quantitative measurement of glucose concentration in fresh capillary whole blood from fingertips to monitor diabetes control. Not for neonatal use, diagnosis, or screening. For single-patient, home-use, in vitro diagnostic self-testing.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• VivaChek™ Ino Smart Blood Glucose Monitoring System (K173140)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 22, 2023

VivaChek Biotech (Hangzhou) Co., Ltd. Mark Qian Quality Director Level 2, Block 2, 146 East Chaofeng Rd. Yuhang Economy Development Zone Hangzhou, Zhejiang 311100 China

Re: K233058

Trade/Device Name: VivaChek™ Link Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: September 20, 2023 Received: September 25, 2023

Dear Mark Oian:

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.

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

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

Sincerely,

Yiduo Wu -S

for 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

Enclosure

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# Indications for Use

510(k) Number (if known) K233058

Device Name

VivaChek™ Link Plus Blood Glucose Monitoring System

Indications for Use (Describe)

VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips.

VivaChek™ Link 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)

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Section F

# Section F: 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 k233058.

## Submitter's Identification:

VivaChek Biotech (Hangzhou) Co., Ltd Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang, China.

Date Updated: Dec 19, 2023

## Contact Person:

Name: Mark Qian Position: Quality Director Email: [e-mail]

## Proprietary Name of the Device:

VivaChek Link Plus 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 Smart Blood Glucose Monitoring System VivaChek Laboratories, Inc. 510(k) Number: k173140

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#### Applicant: 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: [e-mail]

Section F

| Device Name: | | | | | | |
|----------------------------------------------------------|----------------|----------------------|----------------------|-----------------|-----------------------------------------------------|------------------------|
| Proprietary Name | Meter<br>Model | Test Strips<br>Model | Classification | Product<br>Code | Description | Common<br>Name |
| VivaChek Link Plus<br>Blood Glucose<br>Monitoring System | VGM90 | VGS01 | 862.1345<br>Class II | NBW | System, Test,<br>Blood Glucose,<br>Over The Counter | Glucose<br>Test System |

## Intended Use:

VivaChek Link Plus Blood Glucose Monitoring System is comprised of the VivaChek Link Plus Blood Glucose Meter and the VivaChek Ino Blood Glucose Test Strips. VivaChek Link 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.

## Description:

VivaChek Link Plus Blood Glucose Monitoring System 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 oxidase 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 Link Plus Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 2, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.

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Section F

## Comparison to Predicate Device:

The VivaChek Link Plus Blood Glucose Monitoring System is substantially equivalent to VivaChek Ino Smart Blood Glucose Monitoring System (k173140).

| Features | Predicate: VivaChek Ino Smart Blood<br>Glucose Monitoring System (k173140) | Candidate: VivaChek Link<br>Plus Blood Glucose<br>Monitoring System |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | It is intended to quantitatively measure<br>the glucose concentration in fresh<br>capillary whole blood samples drawn<br>from the fingertips. It is intended for use<br>by persons with diabetes at home as an<br>aid to monitor the effectiveness of<br>diabetes control. It is not intended for<br>neonatal use or for the diagnosis of or<br>screening for diabetes. It is intended for<br>self-testing outside the body (in vitro<br>diagnostic use), and should only be<br>used by a single person and should not<br>be shared. | Same |
| Operation Principle | Electrochemical biosensor | Same |
| Detection Method | Amperometric | Same |
| Strip Chemical<br>Composition | Glucose oxidase | Same |
| Measurement Result | Plasma equivalent | Same |
| Sample | Fresh capillary whole blood | Same |
| Memory | 500 records | Same |
| Unit of Measure | mg/dL | Same |
| Measurement Range | 20-600 mg/dL | Same |
| Sample Volume | 0.8µL | Same |
| Test Time | 5 seconds | Same |
| Operating Relative<br>Humidity | 10-90% (non-condensing) | Same |
| Operating Temperature | 41-113°F | Same |
| Hematocrit Range | 20-70% | Same |
| Automatic Shutoff | 2 minutes after last action | Same |
| Power Source | Rechargeable 3.7 Volt Lithium Ion<br>battery | Same |
| Differences | | |
| Battery Type | Rechargeable, non-serviceable,<br>250mAh, 3.7 Volt DC nominal, lithium | Rechargeable, 800 mAh, 3.7<br>Volt DC nominal, lithium<br>polymer battery (5V input) |
| | polymer battery (5V input charge<br>voltage) | charge voltage) |
| Data Transmission | Bluetooth | 4G |
| Dimensions | 83 mm x 52 mm x 18.7 mm | 100.9mm x 61.6mm x 23.7mm |
| Display Size | 32mm x 32 mm | 42 mm x 41 mm |
| Weight | Approximately 53g | Approximately 85g |

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## Applicant: 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: [e-mail]

Section F

## Laboratory and Clinical Testing:

The performance characteristics of the VivaChek Link Plus Blood Glucose Monitoring System were evaluated by performing the following studies:

| No. | Test/Validation Item |
|-----|------------------------------------------------------|
| 1 | Within-Run Precision Evaluation |
| 2 | Intermediate Precision Evaluation |
| 3 | Linearity Evaluation Study |
| 4 | User Evaluation |
| 5 | User Evaluation - Accuracy at Extreme Glucose Values |
| 6 | Usability Evaluation |
| 7 | Interference Agents Study |
| 8 | Accelerated Closed Vial Stability Study |
| 9 | Accelerated Open Vial Stability Study |
| 10 | System Operating Conditions Evaluation |
| 11 | Altitude Effect Evaluation |
| 12 | Error Messages Validation |
| 13 | Short Sample Detection Study |
| 14 | Sample Perturbation Study |
| 15 | Intermittent Sampling Study |
| 16 | Testing with Used Test Strips |
| 17 | Test Strip Early Removal Validation |
| 18 | Incorrect Strip Insertion Validation |

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## Applicant: 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: [e-mail]

Section F

| 19 | Shipping and Handling Study |
|----|-------------------------------------------------------|
| 20 | Oxygen Interference Study |
| 21 | Hematocrit Effect Study |
| 22 | Meter Environmental Temperature Test |
| 23 | Vibration Testing |
| 24 | Shock Testing |
| 25 | Low Battery Study |
| 26 | Recharging Temperature Limit Validation |
| 27 | Cleaning and Disinfection Study |
| 28 | Meter Robustness Study |
| 29 | EMC Testing including the wireless connection testing |
| 30 | Electrical Safety Testing |
| 31 | FCC Testing |
| 32 | Meter Software (Firmware) Validation |
| 33 | Cybersecurity Control DFMEA |
| 34 | Cybersecurity Management Plan |

To confirm the 4G module has not brought any unexpected functional failure or adverse effect, FCC, cybersecurity control DFMEA, Cybersecurity Management Plan and Web App software validation were conducted.

## Discussion of Laboratory Studies:

Above laboratory studies were performed on VivaChek Link Plus Blood Glucose Monitoring System in accordance with the applicable guidance or standards, and the test results indicated that the acceptance criteria were met. Therefore, the performances from these laboratory studies were acceptable.

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Section F

## Discussion of Clinical Study:

Clinical study (user evaluation) was conducted with intended users using the VivaChek Link Plus Blood Glucose Monitoring System. Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the VivaChek Link Plus Blood Glucose Monitoring System. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following the User Manual and the overall performance of the VivaChek Link Plus Blood Glucose Monitoring System.

## Conclusion:

The laboratory studies and user evaluation study results demonstrate that the VivaChek Link Plus Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the VivaChek Link Plus Blood Glucose Monitoring System meets FDA Guidance SMBG for OTC Use.

Based on the same intended use and work principle, and the same technological characteristics listed in the section Comparison to Predicate Device - Similarities, meanwhile the different technological characteristics listed in the section Comparison to Predicate Device do not raise safety and effectiveness questions according to the completed performance testing and validation reports, therefore the candidate device VivaChek Link Plus Blood Glucose Monitoring System is substantially equivalent to the predicate device VivaChek Ino Smart Blood Glucose Monitoring System (k173140).