SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC 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 GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. The SD GlucoNFC 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 GlucoNFC Blood Glucose Test Strips are for use with SD Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm.

SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.

SD GlucoNFC 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, forearm or upper arm and venous whole blood. The SD GlucoNFC 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 GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC 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 GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm and venous whole blood.

SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Multi Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

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

SD GlucoNFC Blood Glucose Monitoring System includes:

SD GlucoNFC Blood Glucose Meter
SD GlucoNFC Blood Glucose Test Strips
SD Glucose Check Strip
SD GlucoNavii® Control Solution – Level 2
Lancet
Lancing device (with a white cap for fingertip testing and a clear cap for Alternative Site Testing)
User Instruction Guide
Test Strip Package Insert
Control Solution Package Insert

SD GlucoNFC Multi Blood Glucose Monitoring System includes

SD GlucoNFC Multi Blood Glucose Meter
SD GlucoNFC Multi Blood Glucose Test Strips
SD Glucose Check Strip
SD GlucoNavii® Control Solution Level 2
User Instruction Guide
Test Strip Package Insert
Control Solution Package Insert

A drop of blood sample works with Glucose dehydrogenase (GDH) and potassium ferrocyanide 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: non-meal, pre-meal and post-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 units. 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 document is a 510(k) Summary for the SD GlucoNFC Blood Glucose Monitoring System and the SD GlucoNFC Multi Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets for each performance metric, nor does it always provide specific numerical results for the device's performance against those criteria. Instead, it generally states that "All the test results met the pre-set criteria."

However, we can infer some criteria and general performance from the "Similarities and Differences" table (Page 7) and the list of conducted tests (Page 9).

Acceptance Criteria (Inferred from tests and comparisons)	Reported Device Performance (as stated or inferred)
Measuring Range	20-600 mg/dL (Same as predicate)
Test Time	5 seconds (Same as predicate)
Operating Temperature (blood sample)	46-113°F (8-45°C) (Different from predicate, but implies meeting its own criteria)
Operating Temperature (control solution)	64-86°F (18-30°C) (Same as predicate)
Operating Humidity	10-90% RH (Different from predicate, but implies meeting its own criteria)
Operating Altitude	Up to 11,548 ft. (Different from predicate, but implies meeting its own criteria)
Hematocrit Range	10-70% (Different from predicate, but implies meeting its own criteria)
Memory Capacity	300 test results (Different from predicate, but deemed "equivalent")
Sample Volume	0.5 µL (Different from predicate, but deemed "equivalent")
Coding	Not Applicable (Same as predicate)
Unit of Measure	mg/dL (Same as predicate)
Electrical Safety	Met pre-set criteria (IEC 61010-1:2001 & IEC 61010-2-101:2002)
Electromagnetic Compatibility	Met pre-set criteria (IEC 60601-1-2)
Radio Frequency	Met pre-set criteria (FCC Part 15.101)
System Accuracy	Met pre-set criteria
Precision	Met pre-set criteria
Linearity	Met pre-set criteria
Matrix comparison	Met pre-set criteria
Interference Substances	Met pre-set criteria
Disinfection / Virucidal Efficacy Validation	Met pre-set criteria
Stability for Test Strip and Control Solution	Met pre-set criteria
Readability for proposed labeling	Met pre-set criteria
Data accuracy & wireless coexistence	Met pre-set criteria
Memory data rollover	Met pre-set criteria
Vibration	Met pre-set criteria
Software Validation	Met pre-set criteria

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

The document explicitly states that "the non-clinical studies and clinical-studies provided in this submission demonstrated that the differences do not raise and effectiveness." The list of tests on page 9 includes "System Accuracy," "Precision," "Linearity," "Sample Volume," "Hematocrit," "Matrix comparison," and "Interference Substances," which typically involve clinical or non-clinical data.

Sample Size: The document does not specify the sample size used for any of the clinical or non-clinical tests (e.g., system accuracy, precision, linearity).
Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It generally refers to "non-clinical studies and clinical-studies."

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

The document is for a Blood Glucose Monitoring System, which measures a quantitative value (glucose concentration). For such devices, the "ground truth" (or reference method) is typically established using a highly accurate laboratory reference instrument, not by human expert consensus or radiologists.

Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth, as typically applied to image-based diagnostic systems, does not directly apply here. The ground truth for glucose measurements would be derived from a laboratory reference method.

4. Adjudication Method for the Test Set

As explained above, for a quantitative measurement device like a blood glucose meter, the ground truth is established by a reference laboratory method rather than by human interpretation requiring adjudication.

Thus, adjudication methods (e.g., 2+1, 3+1) are not relevant to the type of ground truth used for this device.

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

The SD GlucoNFC Blood Glucose Monitoring System is a device designed for direct measurement of blood glucose, not an AI-powered image analysis system that assists human readers in diagnosis.

Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. There is no mention of AI assistance or human readers improving diagnostic accuracy with the device.

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

This device is a standalone glucose measurement system. The blood glucose meter provides a numerical result directly to the user or healthcare professional. There isn't an "algorithm only" component separate from the meter's function, as the meter itself performs the measurement.

The performance metrics like "System Accuracy," "Precision," and "Linearity" inherently represent the standalone performance of the device (the meter and test strip system).

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established against a laboratory reference method that is highly accurate and precise, often a hexokinase or glucose oxidase method run on a clinical chemistry analyzer.

The document implies this by stating "System Accuracy" and "Matrix comparison" tests were performed, which compare the device's readings to a known, precise reference. It does not explicitly name the reference method but it's understood in the context of these devices.
It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document describes premarket notification (510(k)) to demonstrate substantial equivalence, focusing on testing the final device. It does not mention a "training set" in the context of machine learning or AI.

This device is a traditional electrochemical biosensor, not an AI/ML-based system requiring a distinct training dataset.

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

As there is no mention of an AI/ML component or a "training set," this question does not apply to the information provided.

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 stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

SD BIOSENSOR C/O PRISCILLA CHUNG REGULATORY AFFAIRS CONSULTANT 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92831

January 14, 2016

Re: K151265

Trade/Device Name: SD GlucoNFC Blood Glucose Monitoring System. SD GlucoNFC Multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: October 5, 2015 Received: October 09, 2015

Dear Priscilla Chung:

This letter corrects our substantially equivalent letter of November 24, 2015.

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

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Katherine Serrano -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151265

Device Name

SD GlucoNFC Blood Glucose Monitoring System

Indications for Use (Describe)

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151265

Device Name

SD GlucoNFC 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

"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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510(k) Summary (K151265)

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

The assigned 510(k) number is: Date of Summary: November 20, 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 TEL: 82-31-300-0416 FAX: 82-31-300-0497

Contact Person

Ms. Yeon Park / Regulatory 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 GlucoNFC Blood Glucose Monitoring SystemSD GlucoNFC Multi Blood Glucose MonitoringSystem
Common Name:	Blood Glucose Monitoring System
Regulation Number:	21 CFR §862.1345, 21 CFR §862.1660
Classification Name:	Blood Glucose Test System
Product Code:	NBW
Subsequent Product Code:	LFR / JJX
Regulatory Class:	Class IIClass I reserved

3. PREDICATE DEVICES:

SD GlucoMentor™ BGMS (K123517) by SD BIOSENSOR. SD GlucoMentor™ Multi BGMS (K123517) by SD BIOSENSOR

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4. DEVICE DESCRIPTION:

SD GlucoNFC Blood Glucose Monitoring System includes:

SD GlucoNFC Blood Glucose Meter -
-SD GlucoNFC Blood Glucose Test Strips
-SD Glucose Check Strip
-SD GlucoNavii® Control Solution – Level 2
-Lancet
-Lancing device (with a white cap for fingertip testing and a clear cap for Alternative Site Testing)
-User Instruction Guide
-Test Strip Package Insert
-Control Solution Package Insert

SD GlucoNFC Multi Blood Glucose Monitoring System includes

SD GlucoNFC Multi Blood Glucose Meter ।
-SD GlucoNFC Multi Blood Glucose Test Strips
-SD Glucose Check Strip
SD GlucoNavii® Control Solution Level 2 -
-User Instruction Guide
-Test Strip Package Insert
-Control Solution Package Insert

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5. INDICATION FOR USE:

The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC 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 GlucoNFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm.

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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, and then the words "SD BIOSENSOR, INC." in black. The text is in a simple, sans-serif font and is aligned horizontally.

6. COMPARISON TO PREDICATE DEVICE:

The SD GlucoNFC and GlucoNFC Multi Blood Glucose Monitoring Systems are substantially equivalentor™ and SD GlucoMentor™ Multi , K123517. Both the subject and predicate devices are similar in intended use and basic fundamental scientific technology. Please refer to the following similarities and difference comparison chart:

Similarities and Differences
Item	Subject DeviceK151265SD GlucoNFC Blood GlucoseMonitoring System	Subject DeviceK151265SD GlucoNFC Multi BloodGlucose Monitoring System	Predicate DeviceK123517SD GlucoMentor™ BGMS	Predicate DeviceK123517SD GlucoMentor™ MultiBGMS	Discussion ofDifferences
Indications for Use	OTC setting: For Single-User,In-Vitro Diagnostic Use Onlyby Patient (at-home) withDiabetes	POC setting: For Multi-User,In-Vitro Diagnostic Use Onlyby Healthcare Professionalsat Professional Clinic	OTC setting: For Single-User,In-Vitro Diagnostic Use Onlyby Patient (at-home) withDiabetes	POC setting: For Multi-User,In-Vitro Diagnostic Use Onlyby Healthcare Professionalsat Professional Clinic	same
Test Time	5 seconds	5 seconds	5 seconds		same
Measuring Range	20-600 mg/dL		20-600 mg/dL		same
OperatingTemperature	46-113°F (8-45°C) for blood sample64-86°F(18-30°C) for control solution		50-113°F (10-45°C) for blood sample64-86°F (18-30°C) for control solution		different
OperatingHumidity	10-90% RH		15-95% RH		equivalent
Operating Altitude	up to 11,548ft.		up to 11,351ft.		different
Hematocrit	10-70%		20-60%		different
Memory Capacity	300 test results		500 test results		equivalent
Coding	N/A		N/A		same
Meter Dimensions	48mm × 90 mm × 15 mm		47mm x 95mm x 17.5mm		different
Meter Weight	50g with battery		47.5g with battery		different
Unit of measure	mg/dL		mg/dL		same
Sample type	Fresh capillary whole blood	Fresh capillary whole bloodand venous whole blood	Fresh capillary whole blood	Fresh capillary whole blood	different
Sample sites	Fingertip, palm, forearm or upper arm				same
Sample volume	0.5 µL		0.3 µL		equivalent
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

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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 "Y" on the left. To the right of the symbol are the letters "SD" in gray, followed by the words "SD BIOSENSOR, INC." in black.

C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813

Similarities and Differences
Item	Subject DeviceK151265SD GlucoNFC Blood GlucoseMonitoring System	Subject DeviceK151265SD GlucoNFC Multi BloodGlucose Monitoring System	Predicate DeviceK123517SD GlucoMentor™ BGMS	Predicate DeviceK123517SD GlucoMentor™ MultiBGMS	Discussion ofDifferences
Battery Life	Approximately 1,000 Tests
Test StripTechnology	Glucose Dehydrogenase (GDH)		Glucose Oxidase (GOD)		different
Test Principle	Electrochemical biosensor
Sample Application	Test strip capillary draw
Calibration	Plasma-calibrated
Test Strip StorageConditions	Temperature 2-32°C(36-90°F)
PC link Feature	Yes, USB Cable or NFC Reader/Writer		Yes, USB Cable		equivalent
Smart device linkFeature	Yes	Yes	No		different

There are a number of differences between the predicate devices as presented in the table above, however, the non-clinical studies and clinical-studies provided in this submission demonstrated that the differences do not raise and effectiveness. Based on the information provided, we conclude that the subject device is substantially equivalent to the predicate device.

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Image /page/9/Picture/0 description: The image contains a logo with an orange circular icon on the left. Inside the icon is a white stylized letter 'Y'. To the right of the icon are the letters 'SD' in gray, and further to the right are the letters 'SD' in black. The letters 'SD' are smaller than the gray letters.

C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813

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

The following testing was conducted on our subject device:

Software Validation -
Electrical Safety (IEC 61010-1:2001& IEC 61010-2-101:2002) -
Electromagnetic Compatibility (IEC 60601-1-2) -
-Radio Frequency (FCC Part 15.101)
-System Accuracy
-Precision
-Linearity
-Sample Volume
Hematocrit -
-Matrix comparison
-Interference Substances
Operating Condition (Temperature and Humidity) -
-High Altitude
-Disinfection / Virucidal Efficacy Validation and robustness study
Stability for Test Strip and Control Solution -
-Readability for proposed labeling
-Data accuracy & wireless coexistence
Memory data rollover -
Vibration -

All the test results met the pre-set criteria and supported that the subject device is substantially equivalent to the predicate devices in the market.

8. CONCLUSION:

Based on documentation supplied with this submission, conclusions drawn from clinical and bench testing of the subject device demonstrates that the subject devices 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.