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

Indications for 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)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K192957

B Applicant

Vivachek Biotech (Hangzhou) Co., Ltd

C Proprietary and Established Names

VivaChek™ Blood Glucose and β-Ketone Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIN | Class I, meets the limitation of exemption 21 CFR 862.9(c)(5) | 21 CFR 862.1435 - Ketones (Nonquantitative) Test System | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to exterior of a previously cleared blood glucose meter and addition of β-ketone measurement function

B Measurand:

β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood

C Type of Test:

Quantitative amperometry, β-Ketone (beta-hydroxybutyrate)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

K192957 - Page 2 of 9

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
VivaChek™ Blood Glucose and β-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 β-Ketone Test Strips (VKS01).

The VivaChek™ Blood Glucose and β-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or β-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.

### C Special Conditions for Use Statement(s):
OTC - Over The Counter

For single-patient use only. Not for multiple patient use.

Very high (above 65%) and very low (below 20%) hematocrit levels can cause false results. Talk to your healthcare professional to find out your hematocrit level.

The effect of oxygen therapy on the results of this system has not been studied.

Severe dehydration (excessive water loss) may cause inaccurate results.

Not for neonatal use.

Not for use on patients with critical illness.

Not for use in hypotensive individuals or on patients in shock or in a hyperosmolar state.

Not for screening or diagnosis of diabetes.

Do not use the system at altitudes above 13123ft (4000 meters) above sea level for testing.

Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results.

For in vitro diagnostic use only.

The meter is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures.

Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

### D Special Instrument Requirements:
VivaChek™ Blood Glucose and β-Ketone Meter (VGM200)

{2}

K192957 - Page 3 of 9

# IV Device/System Characteristics:

# A Device Description:

VivaChek™ Blood Glucose and β-Ketone Monitoring System consists of a the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01), the VivaChek™ Blood β-Ketone Test Strips (VKS01), blood glucose control solutions, blood β-ketone control solutions, a lancing device, lancets, a user manual, package inserts, quick reference guide warranty card, and carrying case. The device is packaged as a single system (with all components described above), as well as packaged so that subsets of the system components may be purchased separately.

The previously cleared VivaChek™ Ino Plus blood glucose meter (k173140) has been modified to add a ketone measurement function in this submission.

# B Principle of Operation:

The VivaChek™ Blood Glucose and β-Ketone Monitoring System is a quantitative assay for the detection of glucose and/or β-ketone in fresh capillary whole blood samples drawn from the fingertips.

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

# V Substantial Equivalence Information:

# A Predicate Device Name(s):

KetoSens Blood B-Ketone Monitoring System

# B Predicate 510(k) Number(s):

K170463

# C Comparison with Predicate(s):

| Device & Predicate Device(s): | K192957 | K170463 |
| --- | --- | --- |
| Device Trade Name | VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) | KetoSens Blood β-Ketone Monitoring System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the quantitative measurement of β- | Same |

{3}

| Device & Predicate Device(s): | K192957 | K170463 |
| --- | --- | --- |
| | Ketone in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control program. | |
| 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 |
| General Device Characteristic Differences | | |
| Operating Temperature | 41 – 113 °F | 50 – 100 °F |
| Sample Volume | 0.8 μL | 0.5 μL |
| Hematocrit Range | 20–70% | 20–55% |

VI Standards/Guidance Documents Referenced:

CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.

CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline.

CLSI EP25-A Evaluation of Stability of In Vitro diagnostic reagents; Approved Guideline.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Repeatability was assessed using venous whole blood samples adjusted by spiking with D-3-hydroxybutyrate. Each blood ketone concentration was tested in replicates using the

K192957 - Page 4 of 9

{4}

candidate device and with the Randox RANBUT D-3-Hydroxybutyrate assay run on the Randox RX Imola chemistry analyzer, as the comparator method to verify the concentrations. Ten replicates were tested per meter per concentration with each of the three lots of the test strips. The results are summarized below:

| Concentration (mmol/L) | N | Mean | SD | %CV |
| --- | --- | --- | --- | --- |
| 0.1-0.6 | 300 | 0.32 | 0.04 | 11.4% |
| 0.9-1.5 | 300 | 1.30 | 0.06 | 4.7% |
| 2.0-3.0 | 300 | 2.34 | 0.09 | 3.8% |
| 4.0-5.0 | 300 | 4.37 | 0.16 | 3.6% |
| 6.0-8.0 | 300 | 6.76 | 0.24 | 3.6% |

Intermediate Precision study:

Intermediate precision was evaluated using three lots of the blood ketone test strips with 10 meters. Three levels of control solutions were used. For each control, ten replicates were taken each day for ten days, so that 100 individual measurements were generated per control level. The results from all strip lots are summarized below:

| Sample | N | Mean | SD | %CV |
| --- | --- | --- | --- | --- |
| Level 1 | 300 | 0.61 | 0.04 | 6.5% |
| Level 2 | 300 | 2.23 | 0.08 | 3.5% |
| Level 3 | 300 | 4.48 | 0.17 | 3.8% |

2. Linearity:

The linearity of the Ketone Monitoring System was evaluated using venous whole blood spiked with $\beta$-hydroxybutyrate. Twelve whole blood samples were adjusted to the following $\beta$-hydroxybutyrate concentrations: 0.07, 0.25, 0.53, 1.04, 1.79, 2.32, 3.15, 4.14, 5.02, 6.33, 7.37, and $8.52 \mathrm{mmol} / \mathrm{L}$. Each blood ketone concentration was tested on the candidate device, as well as with Randox RANBUT D-3-Hydroxybutyrate assay on the Randox RX Imola chemistry analyzer as a comparator method to determine expected concentration. The summary of the linear regression analysis for each lot was as follow:

| Test Strip Lot | Slope | y-intercept | R² values |
| --- | --- | --- | --- |
| Lot 1 | 1.01 | 0.06 | 0.9989 |
| Lot 2 | 1.00 | 0.00 | 0.9987 |
| Lot 3 | 0.99 | 0.02 | 0.9988 |

The results of the study support the sponsor's claimed (β-ketone) measuring range of 0.1-8.0 mmol/L.

Validation testing was performed demonstrating that the meter displays 'HI' when the measurement result is greater than $8.0\mathrm{mmol / L}$ and "LOW" when the measurement result is less than $0.1\mathrm{mmol / L}$, as intended.

K192957 - Page 5 of 9

{5}

# 3. Analytical Specificity/Interference:

To evaluate interference of exogenous and endogenous interfering substances, three venous whole blood samples with ketone concentrations of $0.4\mathrm{mmol / L}$ , $1.2\mathrm{mmol / L}$ and $4.5\mathrm{mmol / L}$ were divided into two aliquots: control (with no added potential interferent) and test (with assessed potential interferent). Each sample was tested using 10 meters and the difference between meter results obtained with the test sample compared to the control samples calculated. The sponsor defined no significant interference as bias within $0.225\mathrm{mmol / L}$ for $\beta$ -ketone $< 1.5\mathrm{mmol / L}$ and $\leq 15\%$ for $\beta$ -ketone $\geq 1.5\mathrm{mmol / L}$ . The following table lists the highest tested concentration of each substance at which no significant interference was detected:

| Substance | Highest concentration at which no significant interference is observed (mg/dL) |
| --- | --- |
| Acetaminophen | 20 |
| Acetone | 60 |
| Acetoacetate | 20 |
| Ascorbic acid | 3 |
| Acetylsalicylic Acid | 45 |
| Amoxicillin | 12 |
| Ampillicin | 3 |
| Bilirubin | 20 |
| Bicarbonate | 120 |
| Caffeine | 9 |
| Captopril | 10 |
| Cholesterol | 600 |
| Cholic Acid | 6 |
| Clonidine | 1.2 |
| Creatinine | 30 |
| D-(-)-Fructose | 900 |
| D-mannitol | 1000 |
| Dopamine | 13 |
| EDTA | 200 |
| Erythromycin | 20 |
| Estrone | 0.1 |
| Famotidine | 0.15 |
| Fluoxetine HCl | 0.8 |
| Galactose | 100 |
| Gentisic Acid | 50 |
| Glucose | 600 |
| Hemoglobin | 500 |
| Heparin, U/dL | 8000 |
| Ibuprofen | 40 |
| Lactitol | 1000 |
| Lactose | 1000 |

K192957 - Page 6 of 9

{6}

| Substance | Highest concentration at which no significant interference is observed (mg/dL) |
| --- | --- |
| Levo-DOPA | 5 |
| Maltose | 1000 |
| Mannitol | 1000 |
| Metformin HCl | 60 |
| Methyl-Dopa | 10 |
| Metoprolol | 0.27 |
| Reduced Glutathione | 20 |
| Salicylate | 60 |
| Sorbitol | 1000 |
| Tetracycline | 30 |
| Theophylline | 37.5 |
| Tolazimide | 100 |
| Tolbutamide | 100 |
| Triglycerides | 3000 |
| Uric acid | 24 |
| Vitamin E | 15 |
| Xylitol | 1000 |
| Xylose | 1000 |

The labeling includes the following limitations:

- Do not use this system if you are taking vitamin C (ascorbic acid in your blood > 3 mg/dL) since it could cause your glucose and ketone results to be incorrect.
- The system should not be used following xylose absorption procedures.

4. Assay Reportable Range:

0.1 - 8.0 mmol/L

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Traceability:

The VivaChek™ Blood Ketone Monitoring system is traceable to an in-house standard prepared from commercially available control materials. The method comparison / lay user study was performed using the Randox RANBUT D-3-Hydroxybutyrate assay on the RX Imola chemistry analyzer (see Section VII.C.3).

Test strip stability:

The Ketone Test Strips are provided in vials. The shelf life stability was assessed with real-time testing. The study protocol and acceptance criteria were reviewed and found acceptable to support the sponsor's claimed stability of 18 months when stored under recommended storage conditions of 39°F – 86°F (4-30°C) and relative humidity of 10-85%.

K192957 - Page 7 of 9

{7}

6. Detection Limit:

Please refer to the linearity study above.

7. Assay Cut-Off:

Not Applicable.

## B Comparison Studies:

1. Method Comparison with Predicate Device:

See section VII.3.C below for accuracy in the hands of the intended user.

2. Matrix Comparison:

Not applicable. The device is only intended for use with fresh capillary whole blood from a fingerstick.

## C Clinical Studies:

1. Clinical Sensitivity:

Not Applicable.

2. Clinical Specificity:

Not Applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Lay-user accuracy study:

To assess the performance of the VivaChek™ Blood Glucose and β-Ketone Monitoring System in the hands of the intended users, a lay user study was conducted with 102 lay user participants using three lots of ketone test strips. Each lay user participant self-tested their own fingertip capillary blood using the VivaChek™ Blood β-Ketone Monitoring System unassisted and was instructed to use instructions provided in the labeling written in English.

The lay user β-ketone measurements were compared to those obtained with the Randox RANBUT D-3-Hydroxybutyrate assay on the RX Imola chemistry analyzer. The range of β-ketone concentrations across all subjects was 0.11 to 1.52 mmol/L. Each sample was measured in singlicate. The results are summarized below:

Results for samples with β-ketone concentration <1.5 mmol/L:

| Within ± 0.10 mmol/L | Within ± 0.20 mmol/L | Within ± 0.30 mmol/L |
| --- | --- | --- |
| 101/101 (100%) | 101/101 (100%) | 101/101 (100%) |

K192957 - Page 8 of 9

{8}

K192957 - Page 9 of 9

Results for samples with $\beta$-ketone concentration $\geq 1.5$ mmol/L

| Within ± 5% | Within ± 10% | Within ± 20% |
| --- | --- | --- |
| 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |

Linear regression analysis of the results:

| Slope | Intercept | R2 | N | Ketone Concentration (mmol/L) |
| --- | --- | --- | --- | --- |
| 1.0037 | -0.0083 | 0.9927 | 102 | 0.11 to 1.52 mmol/L |

Usability: At the end of the study, each participant was asked to complete a usability questionnaire regarding ease of understanding of information in the user manual and the ease of use when performing a blood glucose test. From the sponsor's analysis of the questionnaire responses, the participants overall were satisfied with the ease of operation by following the instructions for use in the User's Manual and the overall performance of the VivaChek™ Blood Glucose and $\beta$-Ketone Monitoring System.

Readability: The readability of the over-the-counter, home use labeling was evaluated using a Flesch-Kincaid analysis and demonstrated that the grade level scores were less than 8th grade.

## D Clinical Cut-Off:

Not Applicable.

## E Expected Values/Reference Range:

Based on published literature, the sponsor included the following in the labeling:

The normal adult blood $\beta$-Ketone range for a person without diabetes is less than $0.6\ \mathrm{mmol/L}$.

A. Rewers, Current Controversies in Treatment and Prevention of Diabetic Ketoacidosis, Advances in Pediatrics 57 (2010) 247–267.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.