KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

K170463 · I-Sens, Inc. · JIN · Apr 13, 2018 · Clinical Chemistry

Device Facts

• Record ID: K170463
• Device Name: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: JIN · Clinical Chemistry
• Decision Date: Apr 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1435
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

KetoSens Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood β-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared. The KetoSens Blood β-Ketone Test Strips work with the KetoSens Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the fingertip. KetoSens Multi Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood β-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices. The KetoSens Multi Blood β-Ketone Test Strips work with the KetoSens Multi Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.

Device Story

System measures β-hydroxybutyrate in capillary or venous whole blood via electrochemical biosensor technology; uses test strips with β-hydroxybutyrate dehydrogenase enzyme. Meter generates small electrical current proportional to ketone concentration. Used in home (self-test) or professional healthcare settings (Multi version). Healthcare providers/patients use output to monitor diabetes control programs. Provides quantitative ketone levels; aids in managing ketosis/acidosis. Includes meter, test strips, control solutions, lancing device. Multi version requires single-use, auto-disabling lancing devices for infection control.

Clinical Evidence

Bench testing included precision (repeatability %CV 3.5-6.8%; intermediate precision %CV 3.8-7.7%), linearity (R² > 0.998), and interference studies. POC study (n=136) and lay user study (n=185) compared device results to Randox RANBUT d-3-Hydroxybutyrate assay. POC study showed 100% of results within ±0.30 mmol/L for <1.5 mmol/L range and 100% within ±20% for ≥1.5 mmol/L range. Lay user study showed 100% within ±0.225 mmol/L for <1.5 mmol/L range. No clinical data on diagnostic sensitivity/specificity provided as device is for monitoring, not diagnosis.

Technological Characteristics

Electrochemical biosensor; β-hydroxybutyrate dehydrogenase enzyme. Measures 0.1-8.0 mmol/L. Hematocrit range 20-55%. Power: two 3.0V lithium batteries (CR2032). Automatic code identification. Connectivity: standalone meter. Sterilization: not specified. Software: embedded firmware for data processing and memory storage (up to 1,000 records).

Indications for Use

Indicated for quantitative measurement of β-hydroxybutyrate in capillary whole blood (fingertip) and venous EDTA whole blood (Multi version only) to monitor diabetes control effectiveness. Not for diagnosis/screening of diabetes mellitus. Not for use on neonates. Single-patient use (KetoSens) or multiple-patient use (KetoSens Multi) in professional settings.

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

• Nova Max Plus Blood Glucose and β-Ketone Monitoring System (k091547)

Submission Summary (Full Text)

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April 13, 2018

i-SENS, Inc. Joon Ho Jung RA Team Manager 43, Banpo-daero 28-gil, Seocho-gu Seoul, 06646 Korea

Re: K170463

Trade/Device Name: KetoSens Blood β-Ketone Monitoring System KetoSens Multi Blood ß-Ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system C Regulatory Class: Class I, meets limitation of exemptions 21 CFR 862.9(c)(5) Product Code: JIN Dated: April 3, 2018 Received: April 10, 2018

Dear Joon Ho Jung:

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 Part

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801 and Part 809); medical device 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.

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.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] 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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## Indications for Use

510(k) Number (if known) k170463

Device Name KetoSens Blood ß-Ketone Monitoring System

#### Indications for Use (Describe)

KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (betahydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|

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## Indications for Use

510(k) Number (if known) k170463

Device Name

KetoSens Multi Blood ß-Ketone Monitoring System

#### Indications for Use (Describe)

KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.

The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the logo for i-sens. The logo consists of the letter "i" in blue, with a green circle above it. The word "sens" is written in blue next to the "i". The logo is simple and modern.

## 510(k) Summary

#### Introduction 1.

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

| 1.1 | Type of 510(k): | Traditional 510(k) |
|-----|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.2 | Submitter Information: | i-SENS, Inc.<br>43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea<br>Tel.) [phone]<br>Fax) [phone]<br>e-mail: [e-mail]<br>Contact Person: Joon Ho Jung |
| 1.3 | Prepared Date: | April 3, 2018 |

#### 2. Device Name

| <b>2.1 Trade Name</b> | KetoSens Blood β-Ketone Monitoring System |
|--------------------------------|----------------------------------------------------------------------|
| | KetoSens Multi Blood β-Ketone Monitoring System |
| <b>2.2 Classification Name</b> | JIN - Class I, 21 CFR 862.1435 Ketones (nonquantitative) test system |
| | Meets limitations of exemptions 21 CFR 862.9(c)(5) |
| <b>2.3 510k Number</b> | K170463 |

KetoSens Blood B-Ketone Monitoring System and KetoSens Multi Blood B-Ketone Monitoring System are essentially the same product in exception to the product name. The two systems include the same meter, test strips, and control solution with the only difference in the names due to the different indications for use (single vs. multiple-patient use). Due to the nature of the similarities, the candidate device's name of KetoSens Blood ß-Ketone Monitoring System will be used as a representative of the two devices in this submission.

#### Device Description 3.

The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges).

The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.

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The following items are included in the KetoSens Blood ß-Ketone Monitoring System:

- 1 KetoSens Blood ß-Ketone Meter
- 1 Lancing device
- 10 Lancets
- Carrying Case
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 2 Batteries (3.0V lithium batteries)

The following items are included in the KetoSens Multi Blood ß-Ketone Monitoring System:

- KetoSens Multi Blood ß-Ketone Meter
- 1 Owner's Booklet
- 2 Batteries (3.0V lithium batteries)
- Carrying Case

The following items is compatible with the KetoSens Blood ß-Ketone Monitoring System and KetoSens Multi Blood ß-Ketone Monitoring System and is available separately.

- KetoSens (Multi) Blood ß-Ketone Test Strips -
- The KetoSens ß-Ketone Control Solution (Level A and B)

#### Intended Use 4.

#### 4.1 KetoSens Blood ß-Ketone Monitoring System

KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of {}-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood ß-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.

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#### KetoSens Multi Blood ß-Ketone Monitoring System 4.2

KetoSens Multi Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of ß-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with singleuse, auto-disabling lancing devices.

The KetoSens Multi Blood ß-Ketone Test Strips work with the KetoSens Multi Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.

#### Substantial Equivalence Information 5.

The candidate devices are comparable and substantially equivalent to the predicate device.

- 5.1 Predicate Device Name Nova Max Plus Blood Glucose and ß-Ketone Monitoring System Nova Max Blood Glucose and ß-Ketone Monitor -The Nova Max Plus Ketone Test Strips -
- k091547 Predicate 510(k) Number 3.2

#### 6. Comparison with Predicate Devices

## Table 1. The Composition Comparison of the Candidate Devices with the Predicate device

| Device Name | Nova Max Plus Blood Glucose and<br>β-Ketone Monitoring System<br>( <i>Predicate device</i> ) | KetoSens Blood β-Ketone<br>Monitoring System<br>( <i>Candidate device</i> ) |
|-------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Meter | Image: Nova Max Plus Blood Glucose Meter | Image: KetoSens Blood β-Ketone Monitoring System |

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# 43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea
43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea
Tel: [phone] Fax: [phone]

| Device Name | Nova Max Plus Blood Glucose and<br>β-Ketone Monitoring System | KetoSens Blood β-Ketone<br>Monitoring System |
|-------------|------------------------------------------------------------------------------|-------------------------------------------------------------|
| | (Predicate device) | (Candidate device) |
| Test Strips | Image: Nova Max Plus Blood Glucose and β-Ketone Monitoring System Test Strip | Image: KetoSens Blood β-Ketone Monitoring System Test Strip |

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#### 6.1 Similarities and Differences

The candidate device and the predicate device (Ketone) are classified under 21 CFR 862.1435, which states: "A ketones (nonquantitative) est system is a device intended to identify ketones in urine and other body fluids. Identification of ketones 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 kets and patients with diabetes." The predicate device has the capacity to measure both glucose as well as {}- ketone in blood, whereas the can'y measures }- ketone. Substantial equivalence is claimed for the ketone measurement parameter of the predicate device since the of the devices are identical in terms of measuring ketone, and the indications only differ in glucose measuring capabilities between the candidate device and the predicate device.

The intended use for Ketone, operating principle, fundamental scientific technology of the candidate device. The list of similarities and differences between the candidate device and the predicate device are shown in Table 2:

| Item | Nova Max Plus Blood Glucose and<br>β-Ketone Monitoring System<br>(Predicate device) | KetoSens Blood β-Ketone Monitoring System<br>(Candidate device) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Nova Max Plus Blood Glucose and β-Ketone<br>Monitoring System Monitor is intended to be used for the<br>quantitative measurement of glucose in fresh capillary<br>whole blood. It is intended for use by people with<br>diabetes mellitus in the home and by healthcare<br>professionals in clinical settings as an aid to monitor the<br>effectiveness of diabetes control. It is not intended for use<br>in the diagnosis of or screening for diabetes mellitus and<br>is not intended for use on neonates. The Nova Max Blood<br>Glucose and β-Ketone Monitor is specifically indicated<br>for the quantitative measurement of glucose in fresh<br>capillary whole blood samples obtained from the<br>fingertip, forearm and palm and β-hydroxybutyrate (β-<br>ketone) in capillary whole blood from the finger only. | Single-patient use<br>KetoSens Blood β-Ketone Monitoring System is intended to be<br>used for the quantitative measurement of β-Ketone (beta-<br>hydroxybutyrate) level in capillary whole blood samples drawn<br>from the fingertip. The KetoSens Blood β-Ketone Monitoring<br>Systems are for self-testing outside the body (for in vitro<br>diagnostic use) in the home as an aid to monitor the<br>effectiveness of diabetes control program. The system is not<br>intended for use in the diagnosis of or screening for diabetes<br>mellitus and is not intended for use on neonates. This system is<br>intended to be used by a single person and should not be shared.<br>The KetoSens Blood β-Ketone Test Strips work with the<br>KetoSens Blood β-Ketone Meter to quantitatively measure<br>Blood β-Ketone in capillary whole blood samples drawn from<br>the fingertip. |
| | The Nova Max Plus Ketone Test Strips are intended for<br>use only on the Nova Max Plus Blood Glucose and β-<br>Ketone Monitor.<br><br>Nova Max Plus Ketone Control Solutions are intended for<br>use with Nova Max Plus Blood Glucose and β-Ketone<br>Monitor and Nova Max β-Ketone Test Strips as a quality<br>control check to verify the accuracy of blood ketone test<br>results. There are three levels of controls, (Levels 1,2 and<br>3). | The KetoSens β-Ketone Control Solutions are intended for use<br>with the KetoSens Blood β-Ketone meter and KetoSens Blood<br>β-Ketone test strip to check that the meter and the test strip are<br>working together properly and that the test is performing<br>correctly.<br><br>Multiple-patient use<br>KetoSens Multi Blood β-Ketone Monitoring System is intended<br>to be used for the quantitative measurement of β-Ketone (beta-<br>hydroxybutyrate) level in capillary whole blood from the<br>fingertip and venous EDTA whole blood. KetoSens Multi Blood<br>β-Ketone Monitoring System is intended for <i>in vitro</i> diagnostic<br>use and is intended for multiple-patient use in professional<br>healthcare settings as an aid to monitor the effectiveness of<br>diabetes control program. The system is not intended for use<br>in the diagnosis of or screening for diabetes mellitus and is not<br>intended for use on neonates. This system should only be used<br>with single-use, auto-disabling lancing devices. |
| | | The KetoSens Multi Blood β-Ketone Test Strips work with the<br>KetoSens Multi Blood β-Ketone Meter to quantitatively<br>measure Blood β-Ketone in capillary whole blood samples<br>drawn from the fingertip and venous whole blood drawn in<br>professional healthcare settings. |
| | | The KetoSens β-Ketone Control Solutions are intended for use<br>with the KetoSens Multi Blood β-Ketone meter and KetoSens<br>Multi Blood β-Ketone test strip to check that the meter and the<br>test strip are working together properly and that the test is<br>performing correctly. |
| Fundamental scientific technology | | |
| Operating principle | β-hydroxybutyrate (β- ketone) is converted by β-<br>hydroxybutyrate dehydrogenase and the magnitude of | Same |

#### Table 2. The Similarities and Differences between the Candidate Devices and the Predicate Device

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# i·sens

## i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea Tel: [phone] Fax: [phone]

| Page 6 of 18 |
|--------------|
| |

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| | electrical current resulting from this enzymatic reaction | |
|--------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| | is proportional to the amount of β-hydroxybutyrate | |
| | present in the sample. | |
| Assay method | Electrochemical | Same |
| Active reagent | β-hydroxybutyrate dehydrogenase | Same |
| Test measured | Blood Glucose and β-Ketone | Blood β-Ketone |
| Technical specifications | | |
| Sample type | Fresh capillary whole blood (fingertip) | Fresh capillary whole blood (fingertip)<br>Venous EDTA whole blood (multi-patient use only) |
| Hematocrit range | 25%-60% | 20%-55% |
| Operating<br>Temperature Range | 59°F - 86°F | 50 °F ~ 104 °F |
| Operating Relative<br>Humidity | 10%- 90% RH | Same |
| Test time (sec.) | 10 | 8 |
| Memory capacity | Up to 400 | Up to 1,000 |
| Power source | 3 volt coin cell battery CL 2450 | Two 3.0 V lithium batteries (CR2032) |
| Weight | 2.65 oz | 2.53 oz (with batteries) |
| Test range | 0.1 - 8.0 mmol/L | Same |
| Controls | Nova Max Max Plus Ketone Control Solutions<br>(Levels 1, 2, and 3) | KetoSens β-Ketone Control Solutions<br>(Level A and B) |
| Coding | No User Input required for Nova Max | No coding required (Automatic code identification) |

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#### 7. Risk Analysis

We have performed a risk analysis to confirm that risks determined from Preliminary Risk Analysis and severty and to show detailed countermeasures information, warning, indication and design. Based on risk analysis results, we've conducted the performance evaluation tests to confirm the safety and effectiveness of the candidate device.

#### Validation Activity Summary for the Candidate Device 8.

We have conducted the following validation tests to confirm that the candidate device works properly. Table 4 is the summary of the software validation test results for the candidate device. The tests were conducted for Ketone Monitoring System software.

| Test ID and name | Validation activities descriptions | Test results summary |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| MR16-014_3~06<br>Performance Test (Drop,<br>Vibration, Temperature and<br>Humidity exposure limits tests) | Test the performance of meter by<br>dropping, vibrating, and exposing to high<br>or low temperature and high humidity.<br>After the test, check the measurement and<br>operation performance. | Measurement and operation performance of<br>all meters passed the tests. |
| BKM-031F-R021-3<br>Software Function Test | Test the performance of meter based on set<br>criteria. | 100% Compliance |
| BKM-031F-R022-3<br>Memory Test Report | 1st Test is to confirm if the meter operates<br>correctly in full occupied memory<br>condition.<br>2nd Test is to confirm if the memory<br>records and recalls the measured data and<br>calculates average data correctly. 3rd Test<br>is to confirm if the meter calculates<br>average value on leap year correctly. | Average calculated by meter software<br>exactly matched with average calculated<br>manually. |
| BKM-031F-R023-3 | To check if the clock is running<br>accurately for a period of time | It is confirmed that the time differential<br>between the meter and international |

## Table 3. Software Validation Summary

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| Test ID and name | Validation activities descriptions | Test results summary |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Time Test Report | | standard time is within ±15 sec. Therefore, Time function of the meter has been verified. |
| BKM-031F-R024-3<br>DAC Function Test Report | To verify that the reference voltage of the work electrode is 200 mV. | Test result shows that DAC function of the meter has been verified through 10 meters. Therefore, DAC function of the meter has been verified. |
| BKM-031F-R025-3<br>Measurement Timing and ADC<br>Test Report | To verify if the Measurement timing and ADC function works correctly corresponding to the requirement specification. | Test results confirmed that Measurment timing and ADC function of KetoSens has been verified. |
| BKM-031F-R026-3<br>Code Identification Test Report | To verify the automatic code identification (no coding) function of the meter works properly. | Test result shows that code #1~15 have been correctly identified by all meters. |
| BKM-031F-R027-3<br>Power Consumption Test Report | To verify the power consumption in various modes of the meter works properly. | Test result confirmed that the meter has been verified through 10 meters. |
| BKM-031F-R028-3<br>Battery Lifetime Test Report | To verify capable testing times on a continuous measurement condition. | Estimation of the number of times it is capable of testing based on the electrical current consumption and it is possible test about 7320 times. The actual measurement testing was conducted with 2EA the samples. It is assured that the model is capable of testing 3000 times. |

#### Performance Evaluation Summary of the Candidate Device 9.

#### 9.1 Repeatability Test (Report No. BKM-031F-R001)

The purpose of repeatability test is to confirm the precision of Ketone Monitoring System through evaluating test results of blood

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samples obtained by the same user using multiple meters and strip lots.

| Concentration<br>(mmol/L) | N | Mean<br>(mmol/L) | SD<br>(mmol/L) | %CV |
|---------------------------|-----|------------------|----------------|-----|
| 0.4 | 300 | 0.39 | 0.027 | 6.8 |
| 1.1 | 300 | 1.08 | 0.056 | 5.1 |
| 3.4 | 300 | 3.38 | 0.126 | 3.7 |
| 5.2 | 300 | 5.16 | 0.182 | 3.5 |
| 6.9 | 300 | 6.91 | 0.248 | 3.6 |

## Summary results of repeatability test for the KetoSens Blood β-Ketone Monitoring System

### Conclusion:

The pooled SD of concentration intervals 1, 2 were 0.027, 0.056mmo/L respectively that were below 0.075 mmo/L. The pooled CV % of concentration intervals 3, 4 and 5 were 3.7, 3.5 and 3.6%, respectively that were below 5.0 %.

#### Intermediate Precision Test (Report No. BKM-031F-R002) 9.2

The purpose of this intermediate precision test is to evaluate the test dates, other uses, and results tested with other meters in a similar environment using KetoSens Blood {}-Ketone Monitoring System (BKMS) and control solution.

## Organized results for each lot and results summed up

| Control<br>Level | N | Mean<br>(mmol/L) | SD<br>(mmol/L) | %CV |
|------------------|-----|------------------|----------------|-----|
| Level 1 | 600 | 0.63 | 0.049 | 7.7 |
| Level 2 | 600 | 2.23 | 0.085 | 3.8 |
| Level 3 | 600 | 4.04 | 0.173 | 4.3 |

| Page 10 of 18 |
|---------------|

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#### Conclusion:

The pooled SD for concentration interval 1 was 0.049mmol/L that is less than 0.075mmol/L, and the pooled CV for interval 2, 3 were 3.8, 4.3, respectively that are below 5.0 %.

#### Linearity Test (Report No. BKM-031F-R003) 9.3

The purpose of conducting linearity test is to demonstration range (from 0 mmol/L to 8.0 mmo/L) of KetoSens Blood f-Ketone Monitoring System and confirm linearity through Linearity Study.

#### Table 3. Summary results of Linearity test

Strip lot. ML07KEA05B : y = 1.0034x - 0.0145, r2 = 0.9987 Strip lot. ML07KEA10C : y = 1.0250x - 0.0466, r2 = 0.9982 Strip lot. ML08KEA07B : y = 1.0209x - 0.0323, r2 = 0.9982 Total 3 strip lots: y = 1.0159x -0.0303, r2 = 0.9985

### Conclusion:

Linearity test was conducted by measuring the ketone level in the whole blood samples usings. These results were able to obtain the following linear equation and the coefficient of determination (x2) was able to confirm a high linear correlation above 0.95.

#### System Accuracy Test (Report No. BKM-031F-R004) 9.4

The purpose of conducting system accuracy of KetoSens Blood Ketone Monitoring System (BKMS) through clinical evaluation using capillary and venous blood samples. The acuracy of KetoSens is evaluated with capillary blood samples collected from a minimum of 200 sample is evaluated with each of strip lots on one meters run with the KetoSens BKMS and with the standard measurement.

| Item | Result | | |
|-----------------------------------------|----------------------|-----------------------|---------------------|
| ketone<br>concentration<br>< 1.5 mmol/L | Within ± 0.15 mmol/L | Within ± 0.225 mmol/L | Within ± 0.3 mmol/L |

## Summary results of system accuracy test (Capillary blood)

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| | 163/171(95.3%) | 169/171(98.8%) | 170/171(99.4%) |
|-----------------------------------------|------------------|------------------|------------------|
| ketone<br>concentration<br>≥ 1.5 mmol/L | Within<br>± 5 % | Within<br>± 10 % | Within<br>± 20 % |
| | 11/33<br>(33.3%) | 23/33<br>(69.7%) | 33/33<br>(100%) |

All of 204 capillary blood samples (100 %) fell within either = 0.3 mmol/L of the reference measurement procedure at ketone concentrations < 1.5 mmol/L or within ± 20 % at ketone concentrations ≥ 1.5 mmol/L.

| Item | Result | | |
|-----------------------------------------|-------------------------------------------|--------------------------------------------|-----------------------------------------|
| ketone<br>concentration<br>< 1.5 mmol/L | Within ± 0.15<br>mmol/L<br>166/169(98.2%) | Within ± 0.225<br>mmol/L<br>168/169(99.4%) | Within ± 0.3<br>mmol/L<br>169/169(100%) |
| ketone<br>concentration<br>≥ 1.5 mmol/L | Within<br>± 5 %<br>18/35<br>(51.4%) | Within<br>± 10 %<br>28/35<br>(80.0%) | Within<br>± 15 %<br>34/35<br>(97.1%) |
| | | | Within<br>± 20 %<br>35/35<br>(100%) |

## Summary results of system accuracy test (Venous blood)

All of 204 venous blood samples (100 %) fell within either ± 0.3 mmol/L of the reference measurenent procedure at ketone concentrations < 1.5 mmol/L or within ± 20 % at ketone concentrations ≥ 1.5 mmol/L.

#### Hematocrit effect test (Report No. BKM-031F-R005) 9.5

The purpose of this hematocri effect test is to evaluate the effect various heronoming of Ketone testing of Ketone Monitoring System (BKMS). Five different hematocrit levels (20, 30, 42, 50 and 60%) are tested to evaluate the effect of hematocrit level on measurement of ketone concentration. Each of 5 different ketone intervals (in Table 2) is prepared in Twe define concentration is measured using 30 meters and 3 lots of test strips. 10 meters are assigned to each strip lot.

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| Summary results of hematocrit effect test | |
|-------------------------------------------|------------------------------------------------|
| Range (mmol/L) | Average of 3 lots difference<br>(Hct 20 ~ 60%) |
| 0.0 to 0.8 | -0.09~0.02 |
| 1.0 to 2.0 | -7.39~7.83 |
| 2.5 to 3.5 | -10.33~9.05 |
| 4.0 to 5.0 | -13.49~10.72 |
| 5.5 to 6.5 | -15.02~8.73 |

## ry results of hematocrit effect test

## Conclusion:

The hematocrit biases of KetoSens BKMS evaluated (-0.09 ~ 0.02) mmoVL at interval 2, (-10.33 ~ 9.05%) at interval 3, (-13.49 ~ 10.72%) at interval 4 and (-15.02 ~ 8.73%) at interval 5 of hematocrit levels 20 ~ 60%. Thus, the KetoSens BKMS is safe to use with samples containing various levels of hematocrit.

#### Consumer Study (Report No. BKM-031F-R007) 0.6

The purpose of conducting Consumer Study is to evaluate the reads manual, and usability of KetoSens Blood Ketone Monitoring System (BKMS) with accuracy in actual conditions of use. Target users are from various backgrounds in ages and etc. Study subjects are provided with KetoSens BKMS user manual and are allowed to read through the meter. Study subjects perform ketone testing on their own and their testing results are to be compared with the Rx Imola reference values, and also BKMS results obtained by trained staff.

| General user test results | | |
|---------------------------|-----------------------|---------------------|
| Within ± 0.15 mmol/L | Within ± 0.225 mmol/L | Within ± 0.3 mmol/L |
| 183/185(98.9%) | 185/185(100%) | 185/185(100%) |

| Trained user test results | | |
|---------------------------|-----------------------|---------------------|
| Within ± 0.15 mmol/L | Within ± 0.225 mmol/L | Within ± 0.3 mmol/L |

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| 185/185(100%) | 185/185(100%) | 185/185(100%) |
|---------------|---------------|---------------|
|---------------|---------------|---------------|

#### Conclusion:

Total of 185 general users participated in this study. Test subjects were able to perform ketone BKMS on their own by refering to the guidelines in the user manual. These results with Rx Inola reference results and KetoSens BKMS satisfied the system accuracy requirements. Test participants were from various in terms of age, gender, educational level and etc. Regardlessly, the comprehension level of KetoSens BKMS user manual was high. No one answered the use difficult. All of the test participants were able to use KetoSens BKMS correctly and with accurate results. In users have no problem in using KetoSens BKMS in actual conditions of use, and are able to obtain accurate ketone readings with the guidelines in the user manual. In conclusion, lay users have no problem in using. KetoSens BKMS in actual conditions of use, and are able to obtain accurate ketone readings with the help of the user manual.

#### Point-of-Care Test Report (BKM-031F-R008) 9.7

The purpose of conducting Point-of-care test is to evability of KetoSens Multi Blood Ketone Monitoring System by the health care professionals. The accuracy of the BKMS as well as the readability of the user's manual were assessed. This study is conducted at three different sites. The study sites chosen are hospitals for diast two Health Care Professionals perform the blood ketone tests using the KetoSens Multi BKMS at each site. Test participants (sample providers) are diabetic individuals. Health care professionals are provided with the English version of KetoSens Multi BKMS user manual and are allowed to read through the manual. perform blood ketone testing using KetoSens Multi the capillary and venous blood samples without any help from the trained study staff. The study staff operates the reference equipment and modify the KetoSens Multi BKMS results are compared against the reference values.

| β-Ketone concentration <1.5 mmol/L | | | |
|------------------------------------|-----------------------|---------------------|--------------|
| Within ± 0.15 mmol/L | Within ± 0.225 mmol/L | Within ± 0.3 mmol/L | |
| 115/124 (92.7%) | 121/124 (97.6%) | 124/124 (100%) | |
| β-Ketone concentration ≥1.5 mmol/L | | | |
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 2/12 (16.7%) | 8/12 (66.7%) | 11/12 (91.7%) | 12/12 (100%) |

| Venous test | | | | |
|------------------------------------|-----------------------|---------------------|--|--|
| ß-Ketone concentration <1.5 mmol/L | | | | |
| results Within ± 0.15 mmol/L/ | Within ± 0.225 mmol/L | Within ± 0.3 mmol/L | | |
| 113/123 (91.9%) | 118/123 (95.9%) | 121/123 (98.4%) | | |
| | | | | |

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| β-Ketone concentration ≥1.5 mmol/L | | | |
|------------------------------------|---------------|--------------|--------------|
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
| 7/13 (53.8%) | 12/13 (92.3%) | 13/13 (100%) | 13/13 (100%) |

## Conclusion:

POC test is performed by six menbers of Health Care Professional with KetoSens multi Blood β-Ketone monitoring systems (BKMS) at three sites. They have conducted performance test on KetoSens multi a total number of 123 patients, and measured ketone level of patients based only on the manual provided. The KetoSens multi BKMS result is compared against the reference values with Randox Imola, the reference instrument. The comprehension level of KetoSens manual was high. No one answered the use of KetoSens BKMS was diffealt. All of the test HCPs were able to use KetoSens multi accurate results. In conclusion, HCPs have no problems in using the KetoSens multi BKMS in actual conditions of use, and are able to obtain accurate ketone readings with the instructions of the user manual.

## 7.7 Interference Test (Report No. BKM-031F-R006)

The purpose of this interference test is to evaluate the effect interfering substances have on the blood ketone measurements of KetoSens Blood p-Ketone Monitoring System (BKMS). This interference to evaluate the effect of various interfering substances in whole blood samples on ketone measurements.

Two ketone concentrations within the intervals (0.0 ~ 3.5 mmol1) were prepared in blood samples. 29 types of interferents are tested in this test. Stock solution is prepared for each interest using PBS (Phosphate Buffered Saline, pH 7.4) as a solvent. In the case of interferents that do not dissolve in PBS, 0.1M NaOH is used. To minimize change in the matrix when stock solution for each interferent is added, it is prepared by concentrating as much as possible. Each sample is divided into two portions (control and test samples) with respect to one interferent. A concentrated solution of the interferent is added to the solvent used for dissolving the interference substance

is added to the control sample.

| | Difference (mmol/L or %) | | | | | |
|---------------|-------------------------------|----------------|----------------|-------------------------------|----------------|----------------|
| Interferent | Interval 1 (0.0 ~ 0.8 mmol/L) | | | Interval 2 (2.0 ~ 3.5 mmol/L) | | |
| | Strip lot: | Strip lot: | Strip lot: | Strip lot: | Strip lot: | Strip lot: |
| | NF19KEA01<br>A | NF25KEA01<br>A | NF26KEA01<br>A | NF19KEA01<br>A | NF25KEA01<br>A | NF26KEA01<br>A |
| Acetaminophen | -0.06 | -0.03 | -0.02 | -5.4 | -8.3 | -7.0 |
| Ascorbic acid | 0.06 | 0.06 | 0.03 | -0.4 | -0.4 | 1.5 |

## Difference averages interference test

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# i·sens

## i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea Tel: [phone] Fax: [phone]

| Bilirubin | 0.03 | 0.03 | 0.06 | -6.2 | -7.4 | -7.1 |
|-------------|------|------|------|------|------|------|
| Cholesterol | 0.00 | 0.01 | 0.01 | 0.3 | 1.0 | -1.8 |

| | Difference (mmol/L or %) | | | | | |
|------------------|-------------------------------|------------------------------|------------------------------|-------------------------------|------------------------------|------------------------------|
| | Interval 1 (0.0 ~ 0.8 mmol/L) | | | Interval 2 (2.0 ~ 3.5 mmol/L) | | |
| Interferent | Strip lot:<br>NF19KEA01<br>A | Strip lot:<br>NF25KEA01<br>A | Strip lot:<br>NF26KEA01<br>A | Strip lot:<br>NF19KEA01<br>A | Strip lot:<br>NF25KEA01<br>A | Strip lot:<br>NF26KEA01<br>A |
| Creatinine | -0.04 | -0.03 | -0.06 | 3.0 | 3.0 | 4.3 |
| Dopamine | 0.02 | -0.02 | 0.01 | 0.9 | -3.6 | -0.7 |
| EDTA | -0.02 | -0.08 | -0.06 | -2.4 | -5.0 | -6.2 |
| Galactose | 0.01 | -0.03 | -0.01 | 0.1 | 0.9 | 2.2 |
| Gentisic acid | -2.04 | -2.07 | -2.03 | 4.1 | -3.1 | -0.9 |
| Hemoglobin | -0.10 | -0.10 | -0.10 | -1.8 | -2.2 | -3.2 |
| Heparin | 0.00 | -0.04 | -0.07 | -2.5 | -3.3 | -1.8 |
| Ibuprofen | 0.04 | 0.03 | -0.01 | 0.9 | 0.2 | -0.2 |
| L-Dopa | -0.03 | -0.05 | -0.02 | -2.5 | -0.7 | -2.1 |
| Maltose | 0.07 | 0.04 | 0.07 | 3.4 | 1.0 | 2.0 |
| Methyldopa | 0.03 | 0.05 | 0.00 | 2.0 | -0.8 | -2.1 |
| Salicylate | 0.00 | -0.01 | -0.07 | 0.7 | -1.2 | -0.8 |
| Tolazamide | -0.07 | -0.01 | 0.01 | -7.5 | -4.6 | -2.7 |
| Tolbutamide | -0.03 | -0.06 | -0.04 | 4.3 | 2.2 | 3.6 |
| Triglycerides | -0.01 | -0.04 | 0.03 | 0.6 | -0.2 | 3.9 |
| Uric acid | -0.06 | 0.00 | -0.02 | -0.4 | -2.5 | -5.4 |
| Xylose | 0.01 | 0.02 | 0.00 | 1.6 | 0.9 | 0.2 |
| Glutathione(Red) | -0.02 | -0.01 | -0.02 | -1.4 | 0.5 | -2.0 |
| Catopril | -0.04 | -0.02 | 0.00 | -2.3 | -3.1 | -2.9 |
| Tetracycline | -0.02 | -0.05 | -0.05 | -0.7 | -3.2 | -3.6 |
| Glucose | -0.03 | -0.03 | 0.01 | -1.1 | -3.2 | 0.6 |
| Acetone | -0.01 | 0.00 | 0.02 | -3.4 | 1.9 | 0.7 |
| Acetoacetate | -0.06 | 0.00 | 0.00 | -0.1 | 1.0 | -1.8 |

## 7.8 Altitude test report (Report No. BKM-031F-R009)

The purpose of performing altitude test is to evaluate the capability of Ketone Monitoring System (BKMS) to operate normally and to

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Image /page/20/Picture/0 description: The image shows the logo for i-sens. The logo is blue, with a green dot over the "i". The text is sans-serif and bolded.

obtain accurate blood ketone test results at high altitudes (approximately 10,000 feet or 3048m) where the partial pressure of inspired oxygen in the blood decreases.

#### Conclusion:

KetoSens BKMS did not show significant difference with respect to the Rx Imola equipment, nor with different altitudes at all ketone concentrations. Hence it was confirmed that our BKMS have no systematic response to altitudes and is not significantly affected by lack of atmospheric oxygen up to 10,000 feets (3,048m) above the sea level.

#### 7.9 Operating Condition Test (Temperature and Humidity Exposure) (Report No. BKM-031F-R016)

To evaluate the performance of Ketone Monitoring System (BKMS) in the specified operating condition (Temperature and humidity range). Operation condition test is evaluating the performance of KetoSens BKMS within the recommended temperature (10 °C) and humidity (10 % ~ 90 %) in actual conditions of use.

### Conclusion:

Operating condition test was conducted at 9 combined temperature-humidity conditions of 10 °C, 15 °C, 30°, 40% and 90% RH. We have confirmed that KetoSens BKMS operates normally at the presented conditions, individual meter measurements giving less than 0.03 mmol/L or 20 % bias from Rx Imola reference results.

#### Sample Volume (Report No. BKM-031F-R014) 7.10

This is to verify the minimum sample volume used in KetoSens Blood (3-Ketone Monitoring System (BKMS) through testing.

### Conclusion

Sample volume test was performed using wholes from 3 subjects, each divided three concentration intervals. When 0.4 uL of sample was applied to the strip, Er 4 messages appeared.

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Image /page/21/Picture/0 description: The image shows the logo for i-sens. The "i" is blue with a green dot above it. The rest of the word, "-sens" is in blue. The logo is simple and modern.

#### 7.11 Real lifetime test (Report No. BKM-031F-R018)

The purpose of Real-lifetime shelf-life test is to study the stability of KetoSens test and to establish expiry date before opening foil (before being put into use). Three lots of three temperatures of recommended strip storage temperatures (4 °C, 23 °C and 30 °C) at three humidity levels. The study is conducted using blood samples of three ketone concentrations. At every tessing point, strip foil are removed from the designated storage condition. The bias of meter measurement result is compared against the reference values (Rx Imola measurement results) at every ime point, and when the bias exceeds 0.225 mmo/L(for ketone concentration under 1.5 mmo/L) or 10% (for ketone concentration above 1.5 mmol/L), the stability of strip is deemed to have diminished, and the study is initially designed to be conducted for more than 18 months.

### Conclusion:

Stability of KetoSens strip in foil packaging was studied for 499 days using blood samples of 3 ketone concentrations.

## 10. Conclusion

Based on the validation study and the performance evaluations, the candidate devices, KetoSens Monitoring System, is as safe and effective as the predicate device. The results of the KetoSens Blood 3-Ketone Monitoring System is substantially equivalent to the predicate device, Nova Max Plus Blood Glucose and ß-Ketone Monitoring System.