VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sync Blood Glucose Meter (VGM05) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™M Ino Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Simple Blood Glucose Meter (VGM26) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Simple Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Bright Blood Glucose Meter (VGM27) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Bright Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

Device Description

VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model:VGM09), VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26), VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) are designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04), VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09) and VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22) contain Bluetooth, the devices comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Please refer to the FCC PART 15.247 BLE Test Reports #1803WSU007-U1 for VGM09 and VGM22 systems, and #1803WSU007-U2 for VGM04 and VGM05 systems.

VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26)and VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) contain talking functionality, refer to Talking Feature Validation Protocols and Reports, and Meter Robustness Study Protocol and Report.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the VivaChek Ino Blood Glucose Monitoring Systems.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various laboratory and clinical tests conducted. While it doesn't present a single consolidated table of acceptance criteria vs. specific quantitative performance for all metrics, it clearly states "Conclusion | Pass" for all listed tests, indicating that the devices met their respective acceptance criteria based on the referenced guidance documents (primarily FDA SMBG Guidance and ISO 15197:2015).

For system accuracy, the key acceptance criteria for glucose monitoring systems are generally based on ISO 15197. The document indirectly confirms adherence to these by stating the "User Evaluation" and "User Evaluation-Accuracy at Extreme Glucose Values" passed per "FDA SMBG Guidance". The FDA SMBG Guidance often references or aligns with ISO 15197. Without explicit performance data tabled, we infer that the devices met the performance criteria outlined in these guidance documents.

Implied Acceptance Criteria (based on FDA SMBG Guidance and ISO 15197:2015, which the device passed):

Performance Metric	General Acceptance Criteria (per ISO 15197:2015, commonly adopted by FDA)	Reported Device Performance (implied by "Pass")
System Accuracy (compared to reference method)	For glucose concentrations < 100 mg/dL: At least 95% of results shall fall within ± 15 mg/dL of the reference method.	Met (implied by "Pass" for User Evaluation and Accuracy at Extreme Glucose Values)
	For glucose concentrations ≥ 100 mg/dL: At least 95% of results shall fall within ± 15% of the reference method.	Met (implied by "Pass" for User Evaluation and Accuracy at Extreme Glucose Values)
Combined Accuracy (Error Grid Analysis)	For professional use, 100% of results in Zone A and B. For self-testing, high percentage in Zone A and B (specific percentages vary but typically >98%).	Met (implied by "Pass" for User Evaluation)
Linearity	Demonstrated linearity across the measurement range (20 to 600 mg/dL).	Met ("Pass")
Precision (Within-Run & Intermediate)	CV% within specified limits (e.g., < 5% or < 7.5% depending on glucose level).	Met ("Pass" for Intermediate Precision, Within-Run Precision)
Hematocrit Effect	Minimal interference across the specified hematocrit range (20-70%).	Met ("Pass")
Sample Volume	Correct measurement with specified sample volume (0.8 µL).	Met ("Pass")
Interference Agents	Minimal interference from common endogenous and exogenous substances.	Met ("Pass")
Operating Conditions (Temperature, Humidity)	Consistent performance across specified operating ranges (e.g., 41-113°F, 10-90% RH).	Met ("Pass" for Operating Conditions Evaluation)
Stability (Strip, Control, Open/Closed Vial)	Maintain performance over specified shelf-life and in-use period.	Met ("Pass" for most, "In-process" for some real-time studies)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the numerical sample size for the user evaluation (clinical study) or laboratory tests. It generally refers to these studies as being conducted.
Data Provenance: The studies were conducted as part of the 510(k) submission for regulatory clearance in the United States (FDA submission). They are implicitly prospective studies conducted for the purpose of this clearance. No specific country of origin for the data collection is mentioned beyond the context of the FDA submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For glucose monitoring systems, the ground truth is typically established using a highly accurate reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer) rather than a panel of human experts.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth for glucose measurements is established by a reference laboratory method, not by human expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. Blood glucose monitoring systems measure quantitative values, not interpretations like medical images, thus MRMC studies are not relevant for this device type. The document describes "User Evaluation" studies, which focus on whether lay users can correctly operate the device and obtain accurate readings, not on comparing AI assistance versus unassisted human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, in essence, the "Laboratory Testing" section represents the standalone performance of the device's measurement system. Tests like Linearity, Precision, Hematocrit Effect, Sample Volume, and Interference Agents evaluate the accuracy and reliability of the device's core glucose measurement algorithm and hardware independently of user interaction for specific samples. The "User Evaluation" then adds the human-in-the-loop component for intended use.

7. The Type of Ground Truth Used

The ground truth for the glucose measurements was established using a reference laboratory method, which is considered the gold standard for quantitative glucose assessment. While not explicitly named in the provided text, this typically involves a highly accurate laboratory analyzer (e.g., YSI).

8. The Sample Size for the Training Set

This information is not applicable/provided. Blood glucose meters like these are typically based on electrochemical principles and calibration, not on machine learning algorithms trained on large datasets. Therefore, there isn't a "training set" in the sense of AI/ML models. Any internal calibration or development data would not be labeled as a "training set" in the AI/ML context.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's fundamental measurement principle relies on chemistry and electrical current, which are inherently calibrated during manufacturing and design, not "trained" on data.

Summary

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Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

December 19, 2018

VivaChek Laboratories, Inc. Julie Zhou Manager of Regulatory Affair Department 913 N Market Street, Suite 200 Wilmington, DE 19081

Received: November 16, 2018

Re: K173140

Trade/Device Name: VivaChek Ino Smart Blood Glucose Monitoring System VivaChek Ino Sync Blood Glucose Monitoring System VivaChek Ino Sound Blood Glucose Monitoring System VivaChek Ino Plus Blood Glucose Monitoring System VivaChek Ino Sound Simple Blood Glucose Monitoring System VivaChek Ino Sound Bright Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 8, 2018

Dear Julie Zhou:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K173140

Device Name

VivaChek™ Ino Smart Blood Glucose Monitoring System

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

510(k) Number (if known) K173140

Device Name

VivaChek™ Ino Sync Blood Glucose Monitoring System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known) K173140

Device Name

VivaChek™ Ino Sound Blood Glucose Monitoring System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K173140

Device Name

VivaChek™ Ino Plus Blood Glucose Monitoring System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known) K173140

Device Name

VivaChek™ Ino Sound Simple Blood Glucose Monitoring System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{7}------------------------------------------------

510(k) Number (if known) K173140

Device Name

VivaChek™ Ino Sound Bright Blood Glucose Monitoring System

Indications for Use (Describe)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

Section T8

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The Assigned 510(k) number is K173140

Submitter's Identification:

VivaChek Laboratories, Inc. 913 N Market Street, Wilmington, DE, 19801, USA

Tel/Fax.: 302-339-8107

Date Updated: Dec 18, 2018

Contact Person:

Julie Zhou Regulatory Affairs Manager VivaChek Laboratories. Inc. 913 N Market Street, Wilmington, DE, 19801, USA

Proprietary Name of the Device:

VivaChek™ Ino Smart Blood Glucose Monitoring System VivaChek™ Ino Sync Blood Glucose Monitoring System VivaChek™ Ino Sound Blood Glucose Monitoring System VivaChek™ Ino Plus Blood Glucose Monitoring System VivaChek™ Ino Sound Simple Blood Glucose Monitoring System VivaChek™ Ino Sound Bright Blood Glucose Monitoring System

Common Name: Glucose Test System

Classification Name:

Class II §862.1345 Glucose Test System Product code: NBW

Predicate Device:

VivaChek™ Ino Blood Glucose Monitoring System VivaChek Laboratories, Inc. 913 N Market Street, Wilmington, DE, 19801, USA 510(k) Number: K160179

{9}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA

Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Section T8

Device Name:

Proprietary Name	ModelNo.	Classification	ProductCode	Description	CommonName
VivaChek™ Ino SmartBlood GlucoseMonitoring System	VGM04	862.1345Class II	NBW	System, Test, BloodGlucose, Over The Counter	GlucoseTest System
VivaChek™ Ino SyncBlood GlucoseMonitoring System	VGM05	862.1345Class II	NBW	System, Test, BloodGlucose, Over The Counter	GlucoseTest System
VivaChek™ Ino SoundBlood GlucoseMonitoring System	VGM09	862.1345Class II	NBW	System, Test, BloodGlucose, Over The Counter	GlucoseTest System
VivaChek™ Ino PlusBlood GlucoseMonitoring System	VGM22	862.1345Class II	NBW	System, Test, BloodGlucose, Over The Counter	GlucoseTest System
VivaChek™ Ino SoundSimple Blood GlucoseMonitoring System	VGM26	862.1345Class II	NBW	System, Test, BloodGlucose, Over The Counter	GlucoseTest System
VivaChek™ Ino SoundBright Blood GlucoseMonitoring System	VGM27	862.1345Class II	NBW	System, Test, BloodGlucose, Over The Counter	GlucoseTest System

Description:

{10}------------------------------------------------

Section T8

blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

Intended Use:

VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

{11}------------------------------------------------

Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Section T8

body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

{12}------------------------------------------------

Section T8

neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

Technological Characteristics:

Specification of VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04):

Feature	Specification
Measurement range	20 to 600 mg/dL
Test Measured	Glucose in fingertip capillary blood
Sample	Fresh capillary whole blood
Sample volume:	0.8 µL
Test time	5 seconds
Power source	Rechargeable 3.7 Volt Lithium Ion battery
Charging current	100mAh, === Direct current
Battery type	Rechargeable, non-serviceable, 250mAh, 3.7 Volt DC nominal, lithiumpolymer battery (5V input charge voltage)
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)
Memory	Up to 500 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	83 mm x 52 mm x 18.7 mm
Display size	32mm x 32 mm
Weight	Approximately 53g
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%
Data port	Micro USB
Bluetooth	Version 4.1 (syncing with a iPhone for data and time)

Specification of VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05):

Feature	Specification
Measurement range	20 to 600 mg/dL
Test Measured	Glucose in fingertip capillary blood
Sample	Fresh capillary whole blood
Sample volume:	0.8 µL
Test time	5 seconds
Power source	Rechargeable 3.7 Volt Lithium Ion battery
Charging current	100mAh, — Direct current
Battery type	Rechargeable, non-serviceable, 250mAh, 3.7 Volt DC nominal, lithiumpolymer battery (5V input charge voltage)
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)

{13}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Section T8
Memory	Up to 500 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	90.4 mm x 54.5 mm x 27.8 mm
Display size	32mm x 32 mm
Weight	Approximately 53g
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%
Data port	Micro USB
Dimensions	90.4 mm x 54.5 mm x 27.8 mm

Specification of VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09):

Feature	Specification
Measurement range	20 to 600 mg/dL
Test Measured	Glucose in fingertip capillary blood
Sample	Fresh capillary whole blood
Sample volume:	0.8 µL
Test time	5 seconds
Power source	Two AAA LR03 1.5V batteries
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)
Memory	Up to 1000 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	90.4 mm x 54.5 mm x 27.8 mm
Display size	39 mm x 41 mm
Weight	Approximately 63g
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%
Data port	Micro USB
Bluetooth	Version 4.1 (syncing with a iPhone for data and time)

Specification of VivaChek™ Ino Plus Blood Glucose Monitoring System (Model: VGM22):

Feature	Specification
Measurement range	20 to 600 mg/dL
Test Measured	Glucose in fingertip capillary blood
Sample	Fresh capillary whole blood

{14}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA

Contact: Ms. Julie Zhou

Section T8

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Sample volume:	0.8 μL
Test time	5 seconds
Power source	Two AAA LR03 1.5V batteries
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)
Memory	Up to 1000 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	90.4 mm x 54.5 mm x 27.8 mm
Display size	39 mm x 41 mm
Weight	Approximately 63g
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%
Data port	Micro USB
Bluetooth	Version 4.1 (syncing with a iPhone for data and time)

Specification of VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26):

Feature	Specification
Measurement range	20 to 600 mg/dL
Test Measured	Glucose in fingertip capillary blood
Sample	Fresh capillary whole blood
Sample volume:	0.8 µL
Test time	5 seconds
Power source	Two AAA LR03 1.5V batteries
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)
Memory	Up to 1000 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	90.4 mm x 54.5 mm x 27.8 mm
Display size	39 mm x 41 mm
Weight	Approximately 63g
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%

Specification of VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27):

	Feature	Specification
--	---------	---------------

{15}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA Contact: Ms. Julie Zhou Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Section T8
Measurement range	20 to 600 mg/dL
Test Measured	Glucose in fingertip capillary blood
Sample	Fresh capillary whole blood
Sample volume:	0.8 μL
Test time	5 seconds
Power source	Two AAA LR03 1.5V batteries
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)
Memory	Up to 1000 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	90.4 mm x 54.5 mm x 27.8 mm
Display size	39 mm x 41 mm
Weight	Approximately 63g
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%

Comparison to Predicate Devices:

The VivaChek™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) is substantially equivalent to VivaChek™ Ino Blood Glucose Monitoring System (K160179)

Features	VivaChek ™ Ino Blood GlucoseMonitoring System (K160179)	VivaChek ™ Ino Smart Blood GlucoseMonitoring System (Model: VGM04)
	Similarities
Assay Method	Glucose oxidase biosensor	Same
Measurement Range	20 to 600 mg/dL	Same
Strip ChemicalComposition	Glucose oxidase, Mediator	Same
Test Measured	Glucose in fingertip capillary blood	Same
Test Time	5 seconds	Same
Sample Type	Fresh capillary whole blood	Same
Glucose Units ofMeasure	mg/dL	Same
Operating RelativeHumidity	10-90%	Same
Data Port	mini USB	Same
Automatic Shutoff	2 minutes after last action	Same
Minimum Sample Size	0.8µL	Same

{16}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA

Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Section T8

Hematocrit Range	20-70%	Same
OperatingTemperature	5-45°C (41-113°F)	Same
Differences
Alternative SampleSite for Capillary	Palm and forearm in addition tofingertip	None
Meter Memory	Up to 900 records with time and date	Up to 500 records with time and date
Battery Life	12 months or approximately 1,000tests	Rechargeable
Power Source	Two (2) CR 2032 3.0V coin cellbatteries	Rechargeable, non-serviceable, 250mAh,3.7 Volt DC nominal, lithium polymerbattery (5V input charge voltage)
Meter Size	82.5 mm × 52 mm × 18.2 mm	83 mm x 52 mm x 18.7 mm
Meter Weight	Approximately 47g (with batteryinstalled)	Approximately 53g
Bluetooth	None	Yes

The other 5 subject devices (VGM05, VGM09, VGM26, VGM27) are substantially equivalent to VivaChek™ Ino Blood Glucose Monitoring System(K160179)

Features	VivaChek™ Ino Blood GlucoseMonitoring System(K160179)	VGM04	VGM05	VGM09	VGM22	VGM26	VGM27
Intended Use	It is intended to quantitativelymeasure the glucoseconcentration in fresh capillarywhole blood samples drawn fromthe fingertips. It is intended foruse by persons with diabetes athome as an aid to monitor theeffectiveness of diabetes control.It is not intended for neonatal useor for the diagnosis of orscreening for diabetes. Thissystem is intended forself-testing outside the body (invitro diagnostic use), and shouldonly be used by a single personand should not be shared	Same	Same	Same	Same	Same	Same
Assay Method	Glucose oxidase biosensor	Same	Same	Same	Same	Same	Same
Strip ChemicalComposition	Glucose oxidase, Mediator	Same	Same	Same	Same	Same	Same
Test measured	Glucose in fingertip capillarywhole blood	Same	Same	Same	Same	Same	Same
Measurement Range	20 to 600 mq/dL	Same	Same	Same	Same	Same	Same
Test Time	5 seconds	Same	Same	Same	Same	Same	Same
Sample Type	Fresh capillary whole blood	Same	Same	Same	Same	Same	Same
Glucose Units ofMeasure	ma/dL	Same	Same	Same	Same	Same	Same
Operating RelativeHumidity	10-90%	Same	Same	Same	Same	Same	Same
Data Port	mini USB	Same	Same	Same	Same	Same	Same
Automatic Shutoff	2 minutes after last action	Same	Same	Same	Same	Same	Same
Minimum Sample Size	0.8uL	Same	Same	Same	Same	Same	Same
Hematocrit Range	20-70%	Same	Same	Same	Same	Same	Same
Operating Temperature	5-45°C (41-113°F)	Same	Same	Same	Same	Same	Same
Alternative Sample Site	Palm and forearm in addition to	None	None	None	None	None	None

{17}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA

Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

Section	T8

for Capillary	fingertip
Meter Memory	Up to 900 records with time anddate	Up to 500recordswith timeand date	Up to 500recordswith timeand date	Up to 1000recordswith timeand date	Up to 1000recordswith timeand date	Up to 1000recordswith timeand date	Up to 1000recordswith timeand date
Battery Life	12 months or approximately1,000 tests	Rechargeable	Rechargeable	Same	Same	Same	Same
Power Source	Two (2) CR 2032 3.0V coin cellbatteries	Rechargeable,non-serviceable,250mAh,3.7 Volt DCnominal,lithiumpolymerbattery (5Vinput chargevoltage)	Rechargeable,non-serviceable,250mAh,3.7 Volt DCnominal,lithiumpolymerbattery (5Vinput chargevoltage)	Two AAALR03 1.5Vbatteries	Two AAALR03 1.5Vbatteries	Two AAALR03 1.5Vbatteries	Two AAALR03 1.5Vbatteries
Meter Size	82.5 mm × 52 mm × 18.2 mm	83 mm x 52mm x 18.7mm	82 mm x 54 mm x 23 mm	90.4 mm x54.5 mm x27.8 mm	90.4 mm x54.5 mm x27.8 mm	90.4 mm x54.5 mm x27.8 mm	90.4 mm x54.5 mm x27.8 mm
Meter Weight	Approximately 47g (with batteryinstalled)	Approximately 53g	Approximately 53g	Approximately 63g	Approximately 63g	Approximately 63g	Approximately 63g
Bluetooth	None	Yes	Yes	Yes	Yes	None	None
Talking function	None	None	None	Yes	None	Yes	Yes

Laboratory Testing:

The performance characteristics of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems were evaluated by performing the following studies as below:

No.	Test/Validation Item	Reference	Conclusion
1	Linearity Study	FDA SMBG Guidance	Pass
2	User Evaluation	FDA SMBG Guidance	Pass
3	User Evaluation-Accuracy at Extreme GlucoseValues	FDA SMBG Guidance	Pass
4	Accelerated Closed vial Stability Study_Stripwith 65°C	FDA SMBG Guidance	Pass
5	Real Time Open Vial stability Study_Strip	FDA SMBG GuidanceISO 23640	In-process
6	Real Time Extended Open Vial stabilityStudy_Strip	FDA SMBG Guidance	Pass
7	Sample Perturbation Study	FDA SMBG GuidanceISO15197:2015	Pass
8	Accelerated Closed vial Stability Study_Control with 65°C	FDA SMBG Guidance	Pass
Section T8
9	Real Time Open Vial stability Study _Control	FDA SMBG Guidance	Pass
10	Real Time Extend Open Vial stability Study_Control	FDA SMBG Guidance	Pass
11	Hematocrit Effect Study	FDA SMBG Guidance	Pass
12	Sample Volume Study	FDA SMBG Guidance	Pass
13	Intermediate Precision Study	FDA SMBG Guidance	Pass
14	Within-Run Precision Study	FDA SMBG Guidance	Pass
15	Low Battery Study	FDA SMBG Guidance	Pass
16	Altitude Effect Evaluation	FDA SMBG Guidance	Pass
17	Operating Conditions Evaluation	FDA SMBG Guidance	Pass
18	Shipping Study _test strip	FDA SMBG Guidance	Pass
19	Shipping Study_Control	FDA SMBG Guidance	Pass
20	Control Range Assignment	FDA SMBG Guidance	Pass
21	Oxygen Interference Study	FDA SMBG Guidance	Pass
22	Intermittent Sampling Study	FDA SMBG Guidance	Pass
23	Interference Agents Study	FDA SMBG GuidanceISO15197:2015	Pass
24	Real Time Closed Vial Stability Study _StripStudy	FDA SMBG GuidanceISO 23640	In-process
25	Real Time Closed Vial Stability Study _ControlStudy	FDA SMBG Guidance	Pass
26	Meter Robustness Study	FDA SMBG Guidance	Pass
27	Meter Vibration Test	FDA SMBG Guidance	Pass
28	Meter Shock Test	FDA SMBG Guidance	Pass
29	Meter Environmental Temperature Test	FDA SMBG Guidance	Pass
30	Meter Bluetooth Communication Distance Test	Design Specification &FCC Rule Part 15 SubpartC (Section 15.247)	Pass
31	Meter Talking Features (Functionality) Test	Design specification	Pass
32	Error Codes Test	Design specification	Pass
	Section T8
33	Testing with Used Test Strips	Design specification	Pass
34	Meter Software Documentation	Guidance for the Content ofPremarket Submission forSoftware Contained inMedical Devices	Pass
35	GlucoWell App Software Documentation	Guidance for the Content ofPremarket Submission forSoftware Contained inMedical Devices	Pass
36	Electromagnetic Compatibility and Electrical andSafety	IEC 60601-1- 2;IEC 60601-1;IEC 60601-1-11	Pass
37	Cybersecurity (for VGM04, 05, 09, 22)	Cybersecurity forNetworked MedicalDevices Containing OTSSoftware:Content of PremarketSubmission forManagement ofCybersecurity in MedicalDevices	Pass

{18}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA

Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

{19}------------------------------------------------

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA

Contact: Ms. Julie Zhou

Email: julie.zhou@vivachek.com. Tel / Fax: +1-302-339-8107

To confirm bluetooth and talking functionalities have not brought any unexpected functional failure or adverse effect, validation on these functionalities were also conducted, accepted and summarized in above table.

Discussion of Clinical Study:

Clinical (user evaluation) studies were conducted with intended user, lay persons using the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems. The study data were presented evaluating the system accuracy of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems per the VivaChek User Evaluation Study Protocols for these Blood Glucose Monitoring Systems. Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino

{20}------------------------------------------------

Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Glucose Monitoring Systems.

The VivaChek™ Ino Sync (VGM05) has the same intended use, fundamental scientific technology and performance characteristics as VivaChek™ Ino Smart (VGM04). Therefore, the safety, effectiveness and performance are same as the predicate device.

The VivaChek™ Ino Sound Bright (VGM27) has the same intended use, fundamental scientific technology and performance characteristics as VivaChek™ Ino Sound Simple (VGM26). Therefore, the safety, effectiveness and performance are same as the predicate device.

Conclusion:

Section T8

The laboratory testing and user evaluation study results demonstrate that the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple(VGM26) Blood Glucose Monitoring System are safe, effective and easy-to-use. It also demonstrates that the VivaChek™ Ino Smart (VGM04), VivaChek™ Ino Sound (VGM09), VivaChek™ Ino Plus (VGM22), and VivaChek™ Ino Sound Simple (VGM26) Blood Smart Glucose Monitoring Systems meet FDA SMBG Guidance and are substantially equivalent to the VivaChek™ Ino Blood Glucose Monitoring System (K160179). Based on same intended use and technology characteristics, and the test results on user friendly functionalities on bluetooth or talking, the other two subject devices (VGM05, VGM27) are also substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.