(687 days)
Not Found
No
The description focuses on standard blood glucose measurement technology and data transmission via NFC. There is no mention of AI or ML for data analysis, prediction, or interpretation.
No
Explanation: The device is an in vitro diagnostic (IVD) tool used for the quantitative measurement of glucose, aiding in monitoring diabetes control. It does not provide therapy.
No
The text explicitly states: "The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes." and "The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes."
No
The device description explicitly lists hardware components such as a blood glucose meter, test strips, control solution, battery, lancing device, and lancet. While it mentions compatible mobile application or PC software as optional accessories for transmitting data, the core functionality and components are hardware-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the single-patient and multi-patient systems explicitly states: "It is intended for self-testing outside the body (in vitro diagnostic use)" and "is intended for testing outside the body (in vitro diagnostic use)".
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body to provide information about a person's health status (diabetes control). This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 GlucoNavii® 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.
Product codes
NBW, CGA, JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood from fingertip, palm, upper arm, or forearm.
Indicated Patient Age Range
The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates.
The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates
Intended User / Care Setting
Home use for single-patient, professional healthcare settings for multiple-patient use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests performed: 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.
Clinical tests performed: Clinical sensitivity and clinical specificity testing are not applicable. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K132929
Device Name
SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System
Indications for Use (Describe)
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.
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."
3
Indications for Use
510(k) Number (if known) K132929
Device Name
SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System
Indications for Use (Describe)
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.
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."
4
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 NFC
SD 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 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
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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®
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.
7
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 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, or palm.
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
8
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.
9
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 Device
K100398 |
|--------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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-Vitro
Diagnostic Use Only by Patient (at-
home) with Diabetes | OTC setting: For Single-User, In-Vitro
Diagnostic Use Only by Patient (at-
home) with Diabetes
POC setting: For Multi-User, In-Vitro
Diagnostic Use Only by Healthcare
Professionals at Professional Clinic | OTC setting: For Single-User, In-Vitro
Diagnostic Use Only by Patient (at-
home) with Diabetes
POC setting: For Multi-User, In-Vitro
Diagnostic Use Only by Healthcare
Professionals at Professional Clinic |
| Test Time | 5 seconds | | |
| Measuring Range | 20-600 mg/dL | | |
| Operating
Temperature | 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 |
10
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 strip | |
| Automatic 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 Storage | ||
| Temperature | 2-32°C (36-90°F) | |
| Test Strip Storage | ||
| Humidity | 10-95%RH | N/A |
| Control Solution | 2 Levels | |
| Middle: 90-140 mg/dL | ||
| High: 170-240 mg/dL | ||
| PC link Feature | Yes, USB Cable or NFC Reader/Writer | Yes, USB Cable |
| Smart device link | ||
| Feature | Yes | No |
11
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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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.