SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.

SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (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. This system should only be used with auto-disabling, single-use lancing devices.

The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.

SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Device Description

SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-the-counter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. NFC devices contain near field communication (NFC) technology.

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes:

SD GlucoNavii® Mentor NFC Blood Glucose Meter
SD GlucoNavii® Mentor NFC Blood Glucose Test Strips
SD Glucose Check Strip
SD Glucose Control Solution - Level M
3V Battery Type CR2032
User Instruction Guide
Quick Guide
Test Strip Package Insert
Control Solution Package Insert
Carrying Case
Lancing Device, Lancet

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes:

SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter
SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips
SD Glucose Check Strip
SD Glucose Control Solution Level M
3V Battery Type CR2032
User Instruction Guide
Quick Guide
Test Strip Package Insert
Control Solution Package Insert
Carrying Case

Optional software accessory

GlucoNavii® DMS
GlucoNavii®

A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.

The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format usually expected for complex medical imaging devices or AI-driven diagnostic tools. This submission is for a Blood Glucose Monitoring System, which falls under a different regulatory pathway.

However, based on the non-clinical and clinical tests performed, I can extract information related to "System Accuracy" and "User Performance Studies" as the closest equivalent to acceptance criteria and the studies performed.

Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197." ISO 15197 is an international standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus. It defines minimum requirements for system accuracy.

While the exact numerical acceptance criteria from ISO 15197 are not explicitly listed in the document, it's a common standard for blood glucose meters. The document states that "The study results support that SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalence to other predicate devices in the market" and that the testing "met all relevant standards requirements." This implies compliance with ISO 15197.

Based on typical ISO 15197:2013 (or earlier versions like 2003, which might have been relevant in 2015) standards for system accuracy:

Acceptance Criteria (Typical ISO 15197)	Reported Device Performance (Implied)
For glucose concentrations < 100 mg/dL (5.55 mmol/L): Minimum 95% of results shall fall within ±15 mg/dL (±0.83 mmol/L) of the reference method.	The document states, "System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197." It also concludes that "testing met all relevant standards requirements." This implies that the device achieved at least 95% of results within ±15 mg/dL of the reference method for glucose concentrations below 100 mg/dL, in accordance with ISO 15197.
For glucose concentrations ≥ 100 mg/dL (5.55 mmol/L): Minimum 95% of results shall fall within ±15% of the reference method.	Similarly, for glucose concentrations at or above 100 mg/dL, the device is implied to have achieved at least 95% of results within ±15% of the reference method, as required by ISO 15197.
For the combined range: 99% of all individual glucose measurement results shall fall within zone A and B of the Consensus Error Grid.	The document does not explicitly state CEG results, but compliance with ISO 15197 likely indicates adherence to this aspect as well, where 99% of results would fall within clinically acceptable ranges (Zone A and B) on the Consensus Error Grid. The statement "User performance studies were performed to demonstrate that lay consumers could obtain accurate results using the SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems" further supports the device's ability to produce clinically relevant and safe results when used by target users.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for the system accuracy or user performance studies. It only mentions that "System accuracy evaluations... were performed according to ISO 15197" and "User performance studies were performed."

Sample Size: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Studies for regulatory submissions are typically prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The concept of "experts establishing ground truth" is not directly applicable in the same way for a blood glucose monitoring system as it would be for diagnostic imaging or AI.

For blood glucose meters, the "ground truth" (reference method) is typically established by a central laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) which is regularly calibrated and precisely measures glucose concentrations in blood samples. These reference methods are highly accurate and do not rely on a panel of human experts for interpretation.

Number of experts: Not applicable in the context of ground truth for a blood glucose meter. The ground truth is established by a validated laboratory reference instrument.
Qualifications of those experts: Not applicable.

4. Adjudication method for the test set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies in their interpretations to establish a final ground truth. This is not applicable to blood glucose measurement system accuracy where the reference method provides a definitive numerical value.

Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC studies and the concept of "human readers improve with AI vs without AI assistance" are relevant for AI-driven diagnostic tools that augment human interpretation, such as in radiology or pathology. This is not applicable to a standalone blood glucose monitoring system, which provides a numerical measurement directly to the user.

MRMC study: Not applicable.
Effect size of human reader improvement with/without AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A blood glucose monitoring system, by its nature, is a standalone device in terms of its measurement algorithm. The device measures glucose and displays a result. There isn't typically a "human-in-the-loop" influencing the measurement itself, beyond proper sample application and adherence to instructions. The "System Accuracy" and "User Performance" studies evaluate the device's standalone performance (its algorithm and hardware together) and its performance when used by a lay user, respectively.

Standalone performance: Yes, the "System Accuracy" assessment is essentially a standalone performance evaluation against a reference method. The "User Performance Studies" validate that lay users can obtain accurate results, implying the device's performance is robust even with typical user interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for blood glucose monitoring systems is established using a laboratory reference method (e.g., a highly accurate and calibrated glucose analyzer like a YSI instrument). This is considered the gold standard for glucose measurement in such studies.

Type of ground truth: Laboratory reference method.

8. The sample size for the training set

The concept of a "training set" and "testing set" is primarily relevant for machine learning or AI models. While the device likely undergoes extensive internal calibration and development (which could be considered analogous to "training"), the document does not refer to a distinct "training set" in the context of an AI algorithm. For a traditional electrochemical biosensor, the "training" involves optimizing the design, chemical reagents, and electronics using a range of known glucose concentrations during development.

Sample size for the training set: Not specified, and likely not applicable in the AI/ML sense.

9. How the ground truth for the training set was established

As above, the concept of a "training set ground truth" is not directly applicable to this type of device in the same way as AI. The "ground truth" during development and calibration would be established using glucose solutions or blood samples with precisely known glucose concentrations determined by highly accurate laboratory reference methods.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with lines extending above them.

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

August 5, 2015

SD BIOSENSOR, INC. C/O PRISCILLA CHUNG 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92831

Re: K132929

Trade/Device Name: SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: July 24, 2015 Received: July 30, 2015

Dear Priscilla Chung:

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 (OS) 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/ResourcesforYou/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,

Courtney H. Lias -S

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) K132929

Device Name

SD GlucoNavii® Mentor NFC 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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

"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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Indications for Use

510(k) Number (if known) K132929

Device Name

SD GlucoNavii® Mentor NFC Multi 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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

"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 SD Biosensor, Inc. The logo consists of an orange symbol that looks like a stylized tree or plant, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black, with the company name written in a simple, sans-serif font.

510(k) Summary

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

The assigned 510(k) number: K132929

Date of Summary: August 4, 2015

1. SUBMITTER'S IDENTIFICATION:

Manufacturer

SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-Daero,1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813 82-31-300-0418 TEL: FAX: 82-31-300-0497

Contact Person

Ms. Yeon Park / Requlatory Email: py@sdbiosensor.com Official Correspondent (U.S. designated agent) Priscilla Chung (Regulatory Consultant) SD Biosensor, Inc. c/o LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 TEL: (714) 202-5789 FAX: (714) 409-3357 E-MAIL: juhee.c@lkconsultinggroup.com

2. DEVICE NAME:

Proprietary Name:	SD GlucoNavii® Mentor NFCSD GlucoNavii® Mentor NFC Multi
Common Name:	Blood Glucose Monitoring System
Regulation Number:	21 CFR §862.1345
Classification Name:	Blood Glucose Test System
Product Code:	NBW
Subsequent Product Code:	CGA / JJX
Regulatory Class:	II

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Image /page/5/Picture/0 description: The image contains the logo for SD Biosensor, Inc. The logo consists of an orange circular shape with a stylized "Y" inside, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black.

3. PREDICATE DEVICES:

SmartLink™ GOLD Blood Glucose Monitoring System (K100398) by STANDARD DIAGNOSTICS, INC.

4. DEVICEDESCRIPTION:

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes:

-SD GlucoNavii® Mentor NFC Blood Glucose Meter
SD GlucoNavii® Mentor NFC Blood Glucose Test Strips ।
SD Glucose Check Strip -
-SD Glucose Control Solution - Level M
3V Battery Type CR2032
। User Instruction Guide
Quick Guide -
-Test Strip Package Insert
Control Solution Package Insert -
Carrying Case -
Lancing Device, Lancet ।

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes:

SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter ।
-SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips
-SD Glucose Check Strip
SD Glucose Control Solution Level M –
3V Battery Type CR2032 -
-User Instruction Guide
-Quick Guide
Test Strip Package Insert -
Control Solution Package Insert -
-Carrying Case

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Image /page/6/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange abstract symbol resembling a stylized "Y" on the left, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black, with the company name written in a clear, sans-serif font.

Optional software accessory

GlucoNavii® DMS -
। GlucoNavii®

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Image /page/7/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange abstract symbol resembling a stylized tree or branching structure, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black, with the company name written in a clear, sans-serif font.

5. INDICATION FOR USE:

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System

SD Glucollavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The SD GlucoMavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavil® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii@ Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit qlucose values to compatible mobile application or PC software through use of radio frequency communication.

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System

SD Glucollawii@ Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of quose (sugar) in fresh capillary whole blood from finger ip, palm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (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. This system should only be used with auto-disabling, single-use lancing devices.

The SD GlucoMavii® Mentor NFC Multi Blood Gucose Monitoring System should not be used for the diagnosis of or sizening for diabetes. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only

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Image /page/8/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange abstract symbol resembling a stylized plant or tree on the left, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." also in black. The logo is simple and modern, with a focus on the company name and a symbolic representation of life sciences.

during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible application or PC software through use of radio frequency communication.

SD GucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.

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Image /page/9/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange circular graphic to the left, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black.

6. COMPARISION TO PREDICATE DEVICE:

The SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalent to our SD SmartLink™ GOLD Blood Glucose Monitoring System, K100398. Both the subject and predicate devices are similar in intended use and basic fundamental scientific technology.

Please refer to the following similarities and differences comparison chart:

	Subject Device	Subject Device	Predicate DeviceK100398
ltem	SD GlucoNavii® Mentor NFC Blood	SD GlucoNavii® Mentor NFC Multi Blood	SmartLink™ GOLD BGMS
	Glucose Monitoring System	Glucose Monitoring System
Appearance
Indications for Use	OTC setting: For Single-User, In-VitroDiagnostic Use Only by Patient (at-home) with Diabetes	OTC setting: For Single-User, In-VitroDiagnostic Use Only by Patient (at-home) with DiabetesPOC setting: For Multi-User, In-VitroDiagnostic Use Only by HealthcareProfessionals at Professional Clinic	OTC setting: For Single-User, In-VitroDiagnostic Use Only by Patient (at-home) with DiabetesPOC setting: For Multi-User, In-VitroDiagnostic Use Only by HealthcareProfessionals at Professional Clinic
Test Time	5 seconds
Measuring Range	20-600 mg/dL
OperatingTemperature	10-32℃ (50-90℃) for Test Strip / 18-30℃ (64.4-86℃) for Control Solution
Operating Humidity	15-95% RH
Operating Altitude	up to 11,351 feet
Hematocrit	20-60%
Memory Capacity	300 test results		400 test results

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Image /page/10/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange abstract tree-like symbol on the left, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black. The text is in a simple, sans-serif font.

Coding	N/A
Meter Dimensions	50mm x 93mm x 18mm	47mm x 95mm x 17.5 mm
Meter Weight	50g with battery	47.5 with battery
Unit of measure	mg/dL / mmol/L
Sample type	Fresh capillary whole blood
Sample sites	Fingertip, palm, forearm or upper arm
Sample volume	0.3 µL	0.9 µL
Monitor	LCD display
Backlight	No
Power Supply	3V CR2032 Battery x1(Replaceable)
Power Saving	••	Automatic shut off after 1 minute of inactivity WITHOUT inserting test stripAutomatic shut off after 3 minutes of inactivity WITH test strip inserted
Battery Life	Approximately 1,000 Tests
Test Strip Technology	Glucose Oxidase (GOD)
Test Principle	Electrochemical biosensor
Sample Application	Test strip capillary draw
Calibration	Plasma-calibrated
Test Strip StorageTemperature	2-32°C (36-90°F)
Test Strip StorageHumidity	10-95%RH	N/A
Control Solution	2 LevelsMiddle: 90-140 mg/dLHigh: 170-240 mg/dL
PC link Feature	Yes, USB Cable or NFC Reader/Writer	Yes, USB Cable
Smart device linkFeature	Yes	No

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Image /page/11/Picture/0 description: The image contains the logo for SD Biosensor, Inc. The logo consists of an orange abstract symbol resembling a stylized plant or tree, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." also in gray. The overall design is clean and corporate, suggesting a company involved in bioscience or technology.

7. DISCUSSION OF NON-CLINICAL TESTS PERFORMED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE ARE AS FOLLOWS:

Based on our risk analysis evaluation results, and, in accordance with the FDA "Draft Guidance for Industry and FDA Staff – Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems, 10/24/06", outlined performance characteristics, the following testing was conducted to support the modifications found in our subject device:

-Software Validation
Electrical Safety (IEC 61010-1:2001& IEC 61010-2-101:2002) -
Electromagnetic Compatibility (IEC 60601-1-2:2007) -
Radio Frequency (FCC Part 15.255 Subpart C) -
-System Accuracy
-Precision
Linearity -
Sample Volume -
-Hematocrit
Interference Substances -
-Operating Condition (Temperature and Humidity)
High Altitude -
-Disinfection / Virucidal Efficacy Validation
Stability for Test Strip and Control Solution -
Readability for proposed labeling -

None of the testing demonstrated any design characteristics that violated the requirements of the FDA recognized standards or resulted in any safety hazards. It was our conclusion that testing met all relevant standards requirements.

The study results support that SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalence to other predicate devices in the market.

8. DISCUSSION OF CLINICAL TESTS PERFORMED:

Clinical sensitivity and clinical specificity testing are not applicable.

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Image /page/12/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange circular graphic on the left, followed by the letters "SD" in gray. To the right of the letters is the text "SD BIOSENSOR, INC." in black. The text is in a simple, sans-serif font.

System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197.

User performance studies were performed to demonstrate that lay consumers could obtain accurate results using the SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems. The studies were performed using capillary whole blood from fingertip, palm, forearm, and upper arm sample sites.

9. CONCLUSION:

Based on documentation supplied with this submission, conclusions drawn from clinical and bench testing of the subject device demonstrates that the subject devices SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalent to our legally marketed predicate devices.

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.