VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.

The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.

The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

Device Description

The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) 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. The meter is calibrated to display plasma-like concentration results.

All 3 levels control solution consists of glucose in water with buffers and a preservative, and a dye. The device is formulated to provide low, normal and high ducose values representative of low, normal and high blood glucose values in subjects. The active ingredient, glucose, is the same analyte measured in blood specimens by the relevant blood glucose test systems. The proprietary characteristics of the solution have been modified to mimic the measurement of blood specimens with this non - biological, non - toxic, aqueous solution. The product does not contain red blood cells, and so, cannot be used to assess hematocrit effects on glucose measurement. The solution has a red color to enhance its visibility.

AI/ML Overview

The VivaChek™ Ino Blood Glucose Monitoring System underwent various tests to demonstrate its accuracy and establish substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text references compliance with EN ISO 15197:2013, which specifies accuracy requirements for blood glucose monitoring systems. While the exact performance metrics from the VivaChek Ino study are not explicitly listed in a direct comparison table within this document, the overall conclusion states that the device "meets the accuracy requirements per EN ISO 15197."

For blood glucose monitoring systems, EN ISO 15197:2013 typically sets the following accuracy criteria against a laboratory reference method (e.g., YSI):

Acceptance Criteria (EN ISO 15197:2013)	Reported Device Performance (VivaChek™ Ino)
For glucose concentrations < 100 mg/dL (5.55 mmol/L):	Met (Implied by compliance statement)
At least 95% of results within ± 15 mg/dL of reference value	Not explicitly detailed, but implied to be within, as the system "meets the accuracy requirements per EN ISO 15197."
For glucose concentrations ≥ 100 mg/dL (5.55 mmol/L):	Met (Implied by compliance statement)
At least 95% of results within ± 15% of reference value	Not explicitly detailed, but implied to be within, as the system "meets the accuracy requirements per EN ISO 15197."
Overall (combination of both ranges):	Met (Implied by compliance statement)
At least 99% of results in Clarke Error Grid Zone A and B	Not explicitly detailed, but implied to be within.

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

Sample Size:
- The document states that "Clinical studies were conducted with lay persons and trained laboratory technicians." However, it does not specify the exact number of participants or the number of blood samples collected for the clinical study.
Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be a submission to the FDA (USA), but the location of the clinical study is not provided. The study was prospective, as it involved direct testing of the device on participants.

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

Number of Experts: Not applicable in this context. The ground truth for blood glucose monitoring systems is established using a high-accuracy laboratory reference method, not by expert consensus on clinical images or symptoms.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. The clinical study compares the device's readings directly against a laboratory reference method. There is no subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done in the traditional sense for diagnostic image interpretation.
Instead, a clinical study was performed comparing the VivaChek™ Ino Blood Glucose Monitoring System's readings (taken by both lay persons and trained laboratory technicians) against a laboratory reference method (YSI Model 2300 STAT PLUS). This is a direct performance evaluation rather than an MRMC study assessing human reader improvement with AI assistance.

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

Yes, a standalone performance evaluation was done as part of the accuracy assessment. While lay persons and trained technicians performed the tests, the system itself (meter and strips) produces the glucose reading. The study evaluates the accuracy of these readings compared to the reference method, essentially demonstrating the algorithm's performance in generating the glucose value from the blood sample. The role of the human is to properly acquire the sample and operate the device according to instructions, not to interpret an output that the device is assisting them with.

7. The Type of Ground Truth Used

The ground truth used was laboratory reference measurement from the YSI Model 2300 STAT PLUS (K913806). This is considered a highly accurate and precise method for determining blood glucose concentration.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. Blood glucose monitoring systems typically use extensive internal testing, calibration, and potentially clinical data for development and internal validation, which would constitute their "training" analogous to AI. This specific submission focuses on the validation study.

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

The document does not provide information on how the ground truth for any training set was established. For such devices, manufacturing processes, quality control, and instrument calibration against established standards (often traceable to primary reference materials) are crucial during development, serving a similar function to ground truth establishment for a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 21, 2017

VIVACHEK LABORATORIES, INC. JULIE ZHOU MANAGER OF REGULATORY AFFAIR DEPARTMENT 913 N MARKET STREET, SUITE 200 WILMINGTON DE 19081

Re: K160179

Trade/Device Name: VivaChek Ino Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JJX Dated: April 7, 2017 Received: April 10, 2017

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Indications for Use

510(k) Number (if known) K160179

Device Name

VivaChek™ Ino Blood Glucose Monitoring System

Indications for Use (Describe)

VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steadystate times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.

The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.

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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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 K160179

Submitter's Identification:

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

Tel/Fax.: 302-339-8107

Date Prepared: Dec, 2015

Contact Person:

Monica Huang Regulatory Affairs Manager

Proprietary Name of the Device:

VivaChek™ Ino Blood Glucose Monitoring System

Common Name:

Glucose Test System

Classification Name:

Class II §862.1345 Glucose Test System

Predicate Device:

One Touch Ultra Blood Glucose Monitoring System Lifescan, Inc., located at 1000 Gibraltar Dr., Milpitas, CA 95035, USA. K002134

LifeScan One Touch Ultra Control Solution Bionostics, Inc., located at 7Jackson Road, Devens, MA01432, USA. 510(k) Number: K022769

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Proprietary Name	Classification	ProductCode	Description	CommonName
VivaChek™ Ino BloodGlucose Monitoring System	862.1345Class II	75 NBW	System, Test, BloodGlucose, Over The Counter	Glucose TestSystem
VivaChek™ Ino BloodGlucose Meter and BloodGlucose Test Strips	862.1345Class II	75 CGA	Glucose Monitor	GlucoseMeter & TestStrips
VivaChek™ Ino GlucoseControl Solution	862.1660Class I	75 JJX	Single Analyte Control	ControlSolution

Device Name: VivaChek™ Ino Blood Glucose Monitoring System

Description:

Intended Use:

VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood qlucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.

The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.

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Technological Characteristics:

Specification of Blood Glucose Meter:

Feature	Specification
Measurement range	20 to 600 mg/dL
Result calibration	Plasma-equivalent
Sample	Fresh capillary whole blood
Sample volume:	0.8 µL
Test time	5 seconds
Power source	Two (2) CR 2032 3.0 V coin cell batteries
Battery life	12 months or approximately 1,000 tests
Glucose units of measure	The meter is pre-set to milligrams per deciliter (mg/dL)
Memory	Up to 900 records with date and time
Automatic shutoff	2 minutes after last action
Dimensions	82.5 mm × 52 mm × 18.2 mm
Display size	31mm × 37 mm
Weight	Approximately 47g (with battery installed)
Operating temperature	41-113°F
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	20-70%
Data Port	mini USB

Comparison to Predicate Devices:

The VivaChek™ Ino Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System, K002134.

Features	VivaChek™ Ino Blood GlucoseMonitoring System	One Touch Ultra Blood GlucoseMonitoring System (K002134)
Similarities
Assay Method	Glucose oxidase biosensor	Same
Strip ChemicalComposition	Glucose oxidase, Mediator	Same
Result Calibration	Plasma-equivalent	Same
Test Time	5 seconds	Same
Sample Type	Fresh capillary whole blood	Same
Glucose Units ofMeasure	mg/dL	Same
Operating RelativeHumidity	10-90%	Same

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Sponsor: VivaChek Labortatories, Inc.

Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA Contact: Ms. Monica.Huang Email: monica.huang@vivachek.com. Tel / Fax: +1-302-339-8107

Data Port	mini USB	One Serial data port
Automatic Shutoff	2 minutes after last action	Same
Differences
Measurement Range	20 to 600 mg/dL	20 to 600 mg/dL
Minimum Sample Size	0.8 μL	1.0 μL
Hematocrit Range	20–70%	30–55%
OperatingTemperature	5-45°C (41-113°F)	6-44°C (43-111°F)
Alternative SampleSite for Capillary	Palm and forearm in addition to fingertip	Fingertip and forearm
Meter Memory	Up to 900 records with time and date	150 blood glucose and control solutiontests
Battery Life	12 months or approximately 1,000 tests	1,000 tests
Power Source	Two (2) CR 2032 3.0V coin cell batteries	One (1) CR 2032 3.0V coin cell battery
Meter Size	82.5 mm × 52 mm × 18.2 mm	3.12" x 2.25" x 0.85"
Meter Weight	Approximately 47g (with battery installed)	1.5 ounces with battery (Approximately42 g)

Comparison to Predicate Control solution

Similarities and Differences
Item	Proposed DeviceVivaChek™ Ino Control Solution	Predicate Device(K022769)
Indications for use	Same	LifeScan One Touch Ultra controlsolution is intended for use to verifyverify the performance of blood glucosemonitoring system.The control solution is intended for useby healthcare professionals and peoplewith diabetes mellitus at home.For In Vitro Diagnostic Use
Analyte	Same	D-glucose
Matrix	Buffered aqueous solution of D-glucose,preservatives and other non-reactiveingredients.	Buffered aqueous solution of D-glucosea viscosity modifier, preservatives andother non-reactive ingredients.
Number of levels	3	1
Target Value	Approximately 50mg/dL for level1,approximately 120mg/dL for level2 andapproximately 350mg/dL for level3,	Approximately 115mg/dL
Blood Glucose Meters	VivaChek™ Ino	LifeScan OneTouch Ultra

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Guidance documents included the "FDA Guidance for Industry In Vitro Diagnostic Glucose Test System" and "FDA Guidance for Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems" as well as "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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Compliance to applicable voluntary standards includes EN ISO 15197:2013 "In vitro diagnostic test systems – Requirements for in vitro whole blood dlucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."

Laboratory Testing:

The performance characteristics of the VivaChek™ Ino Blood Glucose Monitoring System were evaluated by performing the following studies: repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, strip accelerated stability, strip real time stability, strip real time use life, control value assignment, control solution accelerated stability, control solution real time stability, control solution real time use life, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.

Discussion of Clinical Tests Performed:

Clinical studies were conducted with lay persons and trained laboratory technicians using the VivaChek™ Ino Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the VivaChek™ Ino Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS (K913806) per the VivaChek Clinical Study Protocol for the Blood Glucose Monitoring System. Study results indicate that non-professional, inexperienced lay persons were able to obtain comparable blood qlucose readings when using the VivaChek™ Ino Blood Glucose Monitoring System. In addition, the participating 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 Blood Glucose Monitoring System.

Conclusion:

The laboratory testing and clinical study results demonstrate that the VivaChek™ Ino Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the VivaChek™ Ino Blood Glucose Monitoring System meets the accuracy requirements per EN ISO 15197 and as such is substantially equivalent to the One Touch Ultra Blood Glucose Monitoring System, currently sold on the U.S. market (K002134).

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.