VivaChek Blood Glucose and B-Ketone Monitoring System

K192957 · Vivachek Biotech (Hangzhou) Co., Ltd. · JIN · Jun 5, 2020 · Clinical Chemistry

Device Facts

• Record ID: K192957
• Device Name: VivaChek Blood Glucose and B-Ketone Monitoring System
• Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
• Product Code: JIN · Clinical Chemistry
• Decision Date: Jun 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1435
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and ß-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01). The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) 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 measures β-hydroxybutyrate in fingertip capillary whole blood via amperometric detection; enzyme β-hydroxybutyrate dehydrogenase converts β-hydroxybutyrate to acetoacetate; electrical current magnitude proportional to concentration. Device comprises VGM200 meter, VGS01 glucose strips, VKS01 ketone strips, control solutions, and lancing accessories. Intended for home use by patients with diabetes; single-patient use only. Meter displays quantitative results; aids patients in monitoring diabetes control effectiveness. System includes auto-coding for test strips. Performance validated against Randox RANBUT D-3-Hydroxybutyrate assay. Labeling includes limitations for hematocrit (20-70%), altitude, humidity, and specific interfering substances (e.g., ascorbic acid).

Clinical Evidence

User evaluation study conducted with non-professional, inexperienced lay persons. Participants successfully obtained beta-ketone readings and reported satisfaction with ease of operation and measurement performance. No formal clinical diagnostic accuracy metrics (e.g., sensitivity/specificity) reported; study focused on usability and user-reported satisfaction.

Technological Characteristics

Amperometric sensing; uses beta-hydroxybutyrate dehydrogenase enzyme. Measures glucose (20-600 mg/dL) and beta-ketone (0.1-8.0 mmol/L). Sample volume 0.8 µL. Hematocrit range 20-65%. Power: 2x AAA 1.5V batteries. Connectivity: Bluetooth Low Energy (BLE). Memory: 1000 records. Auto-coding strips.

Indications for Use

Indicated for persons with diabetes for quantitative self-testing of glucose and/or beta-hydroxybutyrate in fresh capillary whole blood from fingertips to monitor diabetes control. Not for neonatal use, diagnosis, or screening.

Regulatory Classification

Identification

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

Predicate Devices

• KetoSens Blood β-Ketone Monitoring System (K170463)

Submission Summary (Full Text)

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June 5, 2020

Vivachek Biotech (Hangzhou) Co., Ltd Mark Qian Quality Director 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou, 311100 China

Re: K192957

Trade/Device Name: VivaChek™ Blood Glucose and B-Ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR 862.9(c)(5) Product Code: JIN Dated: May 11, 2020 Received: May 14, 2020

# 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k192957

Device Name

VivaChek™ Blood Glucose and ß-Ketone Monitoring System

Indications for Use (Describe)

VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and ß-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).

The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) 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) | |
|----------------------------------------------|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |

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Revision: 4

# Section G. 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 k192957

#### Submitter's Identification:

VivaChek Biotech (Hangzhou) Co., Ltd

1/2/3 F, Building 1, 16 East Zhenxing Rd., and Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang, China

Tel: [phone]

Date Updated: Jun 05, 2020

#### Contact Person:

Mark Qian Quality Director

VivaChek Biotech (Hangzhou) Co., Ltd

1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Economy Development Zone, Yuhang, Hangzhou, 311100, Zhejiang, China

#### Proprietary Name:

VivaChek™ Blood Glucose and β-Ketone Monitoring System

#### Common Name:

Blood Glucose and ß-Ketone Test System

#### Classification Name:

Class II 21 CFR §862.1345 Glucose Test System Product code: NBW

Class I, 21 CFR §862.1435 Ketones (nonquantitative) test system, meets limitations of exemptions 21 CFR 862.9(c)(5).

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Revision: 4

Product code: JIN

#### Predicate Device Name:

KetoSens Blood β-Ketone Monitoring System

### Predicate K Number:

K170463

### Description:

VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips.

The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.

VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability. Refer to the relative FCC Test Reports in this submission.

### Intended Use:

VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood ß-Ketone Test Strips (VKS01).

The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or ß-ketone (beta-hydroxybutyrate) 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.

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Revision: 4

# Technological Characteristics:

Specification of VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200):

| Feature | Specification |
|-----------------------|----------------------------------------------------------------------------------------------------|
| Measurement Range | Blood glucose: 20 - 600mg/dL;<br>Blood β-ketone: 0.1 - 8.0 mmol/L |
| Test Measured | Blood Glucose and/or β-Ketone in fingertip capillary whole<br>blood |
| Operating Principle | Amperometric |
| Sample | Fresh capillary whole blood |
| Sample Volume | Blood glucose: 0.8 µL;<br>Blood β-ketone: 0.8 µL |
| Test Time | Blood glucose: 5 seconds;<br>Blood β-ketone: 10 seconds |
| Power Source | Two AAA LR03 1.5V batteries |
| Units of Measure | Blood glucose: Milligrams per deciliter (mg/dL) ;<br>Blood β-ketone: Millimoles per liter (mmol/L) |
| Memory | Up to 1000 records |
| Automatic Shutoff | 2 minutes after last action |
| Operating Temperature | 45.5-113°F |
| Operating RH | 10-90% |
| Hematocrit Range | 20-65% |
| Battery Life | 12 months or approximately 1,000 tests |
| Bluetooth | Bluetooth Low Energy (BLE) |

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Revision: 4

## Comparison to Predicate Device on Technological Characteristics:

VivaChek Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is substantially equivalent to:

| | Predicate Device | Candidate Device |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Features | KetoSens Blood β-Ketone<br>Monitoring System<br>(K170463) | VivaChek™ Blood Glucose and<br>β-Ketone Monitoring System<br>(Model: VGM200) |
| Similarities | | |
| Intended Use | For the quantitative measurement of<br>β-Ketone in fresh capillary whole blood as<br>an aid to monitor the effectiveness of<br>diabetes control program. The system is<br>not intended for use in the diagnosis of or<br>screening for diabetes mellitus and is not<br>intended for use on neonates. This<br>system is intended to be used by a single<br>person and should not be shared. | Same |
| Use Type | Single patient use | Same |
| Specimen | Capillary whole blood from the fingertips | Same |
| Measurement Method | Amperometric | Same |
| Measurement Range | 0.1 - 8.0 mmol/L | Same |
| Strip Active Reagent | β-hydroxybutyrate dehydrogenase | Same |
| Operating Relative Humidity | 10-90% | Same |
| Test Strip Calibration Coding | Auto-coding | Same |
| Differences | | |
| Operating Temperature | 50-100°F | 45.5-113°F |
| Sample Volume | 0.5 µL | 0.8 µL |
| Hematocrit Range | 20-55% | 20-65% |

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Revision: 4

# Laboratory Testing:

The performance characteristics of the VivaChek™ Blood Glucose and β-Ketone Monitoring System were evaluated by performing the following non-clinical studies:

| No. | Study | Conclusion |
|-----|----------------------------------------------------|------------|
| 1 | Linearity Study | Pass |
| 2 | User Evaluation | Pass |
| 3 | Accelerated Closed Vial Test Strip Stability Study | Pass |
| 4 | Accelerated Closed Control Stability Study | Pass |
| 5 | Accelerated Open Vial Test Strip Stability Study | Pass |
| 6 | Real Time Open Vial Test Strip Stability Study | Pass |
| 7 | Hematocrit Effect Study | Pass |
| 8 | Sample Volume Study | Pass |
| 9 | Intermediate Precision Study | Pass |
| 10 | Within-Run Precision Study | Pass |
| 11 | Altitude Effect Evaluation | Pass |
| 12 | Operating Conditions Evaluation | Pass |
| 13 | Shipping Study for Ketone Test Strip | Pass |
| 14 | Shipping Study for Ketone Control | Pass |
| 15 | Interference Agents Study | Pass |
| 16 | Error Codes Test | Pass |
| 17 | Meter Environmental Temperature Test | Pass |
| 18 | Testing with Used Test Strips | Pass |
| 19 | Meter Software Documentation | Pass |
| 20 | Meter Robustness Study | Pass |

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Revision: 4

## Brief Discussion of Non-Clinical Studies:

Above non-clinical (laboratory) studies were performed on the VivaChek™ Blood Glucose and ß-Ketone Monitoring System in accordance with the corresponding study protocols, and the test results indicated that the acceptance criteria were met. Therefore the ketone performances from these non-clinical (laboratory) studies were acceptable.

## Brief Discussion of Clinical Study:

User evaluation study was conducted in accordance with the User Evaluation Study Protocol on VivaChek™ Blood Glucose and ß-Ketone Monitoring System. Study results indicated that non-professional, inexperienced lay persons were able to obtain ß-ketone readings when using the VivaChek™ Blood Glucose and β-Ketone Monitoring System. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following User Manual and the overall ketone measurement performance of the VivaChek™ Blood Glucose and β-Ketone Monitoring System.

## Conclusion:

The non-clinical (laboratory) studies and clinical (user evaluation) study results have demonstrated that the VivaChek™ Blood Glucose and β-Ketone Monitoring System is safe, effective and easy-to-use, besides it demonstrated that the VivaChek™ Blood Glucose and B-Ketone Monitoring System meets applicable CLSI guidelines, and also based on the similarities described in the table of Comparison to Predicate Device on Technological Characteristics in this 510(k) summary. VivaChek™ Blood Glucose and ß-Ketone Monitoring System is substantially equivalent to the KetoSens Blood ß-Ketone Monitoring System (K170463).