(233 days)
Not Found
No
The description focuses on standard blood glucose measurement technology and data transfer features, with no mention of AI or ML algorithms for analysis or prediction.
No
This device is a diagnostic tool used to measure blood glucose levels, aiding in the monitoring of diabetes control. It does not provide treatment or therapy.
No
This device is specifically stated "should not be used for the diagnosis of or screening for diabetes." Instead, it is intended to aid in monitoring the effectiveness of diabetes control.
No
The device description explicitly details hardware components such as a printed circuit board (PCB), a Bluetooth module, and electronic components, indicating it is a physical device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "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." and "The SD GlucoNavii® Mentor BT 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 clearly indicates that the device is designed to perform tests on samples taken from the human body (blood) outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SD GlucoNavii® Mentor BT 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 BT 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 BT Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor BT 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 BT Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT 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 BT 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 BT 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 BT Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor BT 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 BT Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT 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 (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
SD GlucoNavii® Mentor BT and BT Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor BT 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 BT 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.
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 and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The system can also set the pre-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.
A Bluetooth unit for data transfer has been added to the subject devices in addition to NFC and USB cable communication features.
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
Not for use in neonates.
Intended User / Care Setting
SD GlucoNavii® Mentor BT Blood Glucose Monitoring System: single person, self-testing, at home.
SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System: multiple-patient use in professional healthcare settings.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are depicted in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
SD BIOSENSOR C/O PRISCILLA CHUNG LK CONSULTING GROUP, USA, INC. 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92831
Re: K153201
Trade/Device Name: SD GlucoNavii® Mentor BT Blood Glucose Monitoring System, SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: May 23, 2016 Received: May 26, 2016
Dear Ms. 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,
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
2
Indications for Use
510(k) Number (if known) K153201
Device Name
SD GlucoNavii® Mentor BT Blood Glucose Monitoring System
Indications for Use (Describe)
SD GlucoNavii® Mentor BT 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 BT 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 BT Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor BT 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 BT Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT 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) |
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."
3
Indications for Use
510(k) Number (if known) K153201
Device Name
SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System
Indications for Use (Describe)
SD GlucoNavii® Mentor BT 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 BT 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 BT Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor BT 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 BT Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT 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) |
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."
4
Image /page/4/Picture/0 description: The image contains the logo for SD Biosensor, Inc. The logo features an orange abstract symbol resembling a stylized flame or plant on the left. To the right of the symbol, the text "SD BIOSENSOR, INC." is displayed in a simple, sans-serif font. The letters "SD" are larger and in gray, while the rest of the text is in black.
510(k) Summary
(K153201)
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
Date of Summary: June 22, 2016
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: 82-31-300-0423 FAX: 82-31-300-0497
Contact Person
SunYoung Jeong Email: syj@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 BT Blood Glucose Monitoring System
SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Glucose Monitoring System |
| Regulation Number: | 21 CFR §862.1345 |
| Classification Name: | Blood Glucose Test System |
| Product Code: | NBW |
| SubsequentProduct Code: | CGA |
| Regulatory Class: | II |
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3. PREDICATE DEVICES:
SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System and SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System (K132929) by SD Biosensor, Inc.
4. DEVICEDESCRIPTION:
SD GlucoNavii® Mentor BT and BT Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is indicated for singlepatient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-thecounter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control.
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 and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The system can also set the pre-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.
A Bluetooth unit for data transfer has been added to the subject devices in addition to NFC and USB cable communication features.
The following modifications were made on the subject device from the predicate device (K132929).
-
- The addition of Bluetooth for wireless transmission of data to mobile device or PC, and which comprises the following modifications:
- i. Changed printed circuit board (PCB) layout.
- ii. Added Bluetooth module to PCB.
- iii. Added and deleted electronic components to support the Bluetooth Module.
- iv. Deleted USB communication circuit.
- Changed Firmware. V.
- Added Bluetooth icon to display. vi.
- Extended automatic meter shutoff times to allow enough time for data transfer via Bluetooth. vii.
-
- Memory capacity for stored glucose test results decreased from 300 to 100 records.
-
- The trade name of the systems has changed from SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System and SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System to SD GlucoNavii® Mentor BT Blood Glucose Monitoring System and SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System.
6
C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813
-
- The trade name of the test strips has changed from SD GlucoNavii® Mentor NFC Blood Glucose Test Strips and SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips to SD GlucoNavii® Mentor BT Blood Glucose Test Strips and SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips.
-
- Labeling was modified to reflect the changes to the device.
7
5. INDICATION FOR USE:
SD GlucoNavii® Mentor BT Blood Glucose Monitoring System
SD GlucoNavii®Mentor BT 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 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 by people with diabetes at home as an aid to monitor the effectiveness of diabetes ontrol.
The SD Gluccilentor BT Blood Glucose Montoning System should not be used for the diabetes. The SD GlucoNavi™Mentor BT Blood Glucose Monitoring System is not for use in neonates . Alternative site done only during steady-state times (when glucose is not changing rapidly).
SD GlucoNavii®Mentor BT Blood Glucose Test Strips are with SD GlucoNavii®Mentor BT Blood Glucose Meter to quantitatively measure glucose (succee (succee (succee (succee (succ capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System
SD Glucollari®Mentor BT Multi Blood Glucose Monitative mesurement of glucose (sugaritiative messurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or foreari® Nentor BT Multi Blood Guccose Monitoring System is intended for testing outside the body in vitro diagnosic use) and is intended for multiple-patings as an aid to monitor the effectivenes of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.
The SD Gucollari®Mentor BT Multi Blood Goose Montoning System should not be used for the diabets. The SD Gucollari® Nentor BT Multi Blood Glucose Monitoring System is not for use in news in testing should be done only during steady-state times (when glucose is not thanging rapidly).
SD GlucoNavii®Mentor BT Multi Blood Glucose with SD GlucoNavii®Mentor BT Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
8
6. COMPARISION TO PREDICATE DEVICE:
The subject devices are substantially equivali® Mentor NFC and Mentor NFC Multi Blood Glucose Monitoring System, cleared under K132929. Both the subject and predicate devices are the same in intended uses and basic fundamental scientific technology. Please refer to the following similarities and difference comparison chart:
| Similarities and Differences | ||||
|---|---|---|---|---|
| Item | Unmodified device | |||
| (K132929) | Modified(subject) device | |||
| (K153201) | Discussion of | |||
| Differences | ||||
| Trade Name | SD GlucoNavii® Mentor NFC Blood | |||
| Glucose Monitoring System | ||||
| SD GlucoNavii® Mentor NFC Multi | ||||
| Blood Glucose Monitoring System | SD GlucoNavii® Mentor BT Blood | |||
| Glucose Monitoring System | ||||
| SD GlucoNavii® Mentor BT Multi | ||||
| Blood Glucose Monitoring | ||||
| System | different | |||
| Manufacturer | SD Biosensor, Inc. | SD Biosensor Inc. | identical | |
| Product Code | CGA, NBW | CGA, NBW | identical | |
| 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 | 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 | identical | |||
| Similarities and Differences | ||||
| Item | Unmodified device | |||
| (K132929) | Modified(subject) device | |||
| (K153201) | Discussion of | |||
| Differences | ||||
| 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. | GlucoNavii®Mentor BT 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 BT Blood
Glucose Test Strips are for use with
SD GlucoNavii® Mentor BT Blood
Glucose Meter to quantitatively
measure glucose (sugar) in fresh
capillary whole blood samples
drawn from the fingertips, forearm,
upper arm, or palm. | 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
be used 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. | diagnosis of or screening for
diabetes. The SD GlucoNavii®
Mentor BT 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 BT Multi
Blood Glucose Test Strips are for
use with SD GlucoNavii® Mentor BT
Multi Blood Glucose Meter to
quantitatively measure glucose
(sugar) in fresh capillary whole
blood samples drawn from the
fingertips, forearm, upper arm, or
palm. |
| Test Time | | | 5 seconds | identical |
| Measuring Range | | | 20-600 mg/dL | identical |
| Operating Temperature | | | 10-45°C (50-113°F) for blood sample / 18-30°C (64-86°F) for control solution | identical |
| Operating Humidity | | | 15-95% RH | identical |
| Operating Altitude | | | up to 11,351ft. | identical |
| Hematocrit | | | 20-60% | |
| Memory Capacity | 300 test results | | 100 test results | different |
| Coding | | | N/A | identical |
| Meter Dimensions | | | 50mm x 93mm x 18mm | identical |
| Meter Weight | | | 50g with battery | identical |
| Similarities and Differences | | | | |
| Item | Unmodified device
(K132929) | Modified(subject) device
(K153201) | Discussion of
Differences | |
| Unit of measure | mg/dL | mg/dL | identical | |
| Sample type | Fresh capillary whole blood | Fresh capillary whole blood | identical | |
| Sample sites | Fingertip, palm, forearm or upper arm | Fingertip, palm, forearm or upper arm | identical | |
| Sample volume | 0.3 µL | 0.3 µL | identical | |
| Monitor | LCD display | LCD display | identical | |
| Backlight | No | No | identical | |
| Power Supply | 3V CR2032 Battery x1(Replaceable) | 3V CR2032 Battery x1(Replaceable) | identical | |
| Power Saving | Automatic shut off after 1 minute of inactivity WITHOUT inserting test strip / after 3 minutes of inactivity WITH test strip inserted | Automatic shut off after 1 minute of inactivity WITHOUT inserting test strip / after 3 minutes of inactivity WITH test strip inserted | identical | |
| Battery Life | Approximately 1,000 Tests | Approximately 1,000 Tests | identical | |
| Test Strip Technology | Glucose Oxidase (GOD) | Glucose Oxidase (GOD) | identical | |
| Test Principle | Electrochemical biosensor | Electrochemical biosensor | identical | |
| Sample Application | Test strip capillary draw | Test strip capillary draw | identical | |
| Calibration | Plasma-calibrated | Plasma-calibrated | identical | |
| Test Strip Storage
Temperature | 2-32°C(36-90°F) | 2-32°C(36-90°F) | identical | |
| Test Strip Storage
Humidity | 10-95%RH | 10-95%RH | identical | |
| PC link Feature | Yes, USB Cable or NFC | Yes, NFC, or Bluetooth | different | |
| Smart device link Feature | Yes, NFC | Yes, NFC or Bluetooth | different | |
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Image /page/9/Picture/0 description: The image contains 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 company name "SD BIOSENSOR, INC." in black.
C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813
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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 symbol resembling a stylized "Y" shape, 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.
C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813
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DR, INC.
C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813
7. DISCUSSION OF NON-CLINICAL TESTS PERFORMED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE ARE AS FOLLOWS:
There are a number of differences between the unmodified devices and the modified devices as presented in the table above in section 6, however, the differences were evaluated through design control, risk analysis and verification & validation activities, and test results demonstrated that the differences do not raise a question of safety and effectiveness. Based on the information provided in this submission, we conclude that the modified device is substantially equivalent to the predicate device.
8. DISCUSSION OF CLINICAL TESTS PERFORMED:
Clinical sensitivity and clinical specificity testing are not applicable.
9. CONCLUSION:
Based on documentation supplied with this submission, conclusions drawn from design control, risk and verification & validation activities demonstrate that the subject devices are substantially equivalent to the predicate devices.