(195 days)
Not Found
No
The document describes a standard blood glucose monitoring system that measures electrical current proportional to glucose concentration. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as a blood glucose monitoring system, intended for quantitative measurement of glucose, which is a diagnostic purpose to monitor the effectiveness of diabetes control, not for direct therapeutic intervention.
No
The text explicitly states: "The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes." and "The SD GlucoNFC 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, lancet, and lancing device, in addition to software functionalities.
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 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."
The device description also refers to the systems as "OTC/ Rx blood glucose monitoring systems" and describes how they measure glucose in blood samples, which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
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.
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, forearm or upper arm, venous whole blood.
Indicated Patient Age Range
The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates.
The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates.
Intended User / Care Setting
Home use for self-testing by people with diabetes; 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)
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.
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 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
1
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
2
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)
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.
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."
3
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)
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.
| 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
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 System
SD GlucoNFC Multi Blood Glucose Monitoring
System |
|--------------------------|-----------------------------------------------------------------------------------------------------|
| 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 II
Class I reserved |
3. PREDICATE DEVICES:
SD GlucoMentor™ BGMS (K123517) by SD BIOSENSOR. SD GlucoMentor™ Multi BGMS (K123517) by SD BIOSENSOR
5
4. 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.
6
5. INDICATION FOR USE:
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 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.
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.
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, 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 Device | ||||
| K151265 | |||||
| SD GlucoNFC Blood Glucose | |||||
| Monitoring System | Subject Device | ||||
| K151265 | |||||
| SD GlucoNFC Multi Blood | |||||
| Glucose Monitoring System | Predicate Device | ||||
| K123517 | |||||
| SD GlucoMentor™ BGMS | Predicate Device | ||||
| K123517 | |||||
| SD GlucoMentor™ Multi | |||||
| BGMS | Discussion of | ||||
| Differences | |||||
| Indications for Use | 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 | same | ||||
| Test Time | 5 seconds | 5 seconds | 5 seconds | same | |
| Measuring Range | 20-600 mg/dL | 20-600 mg/dL | same | ||
| Operating | |||||
| Temperature | 46-113°F (8-45°C) for blood sample | ||||
| 64-86°F(18-30°C) for control solution | 50-113°F (10-45°C) for blood sample | ||||
| 64-86°F (18-30°C) for control solution | different | ||||
| Operating | |||||
| Humidity | 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 blood | |||
| and 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 strip | ||||
| Automatic shut off after 3 minutes of inactivity WITH test strip inserted |
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 "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 Device | ||||||||
| K151265 | |||||||||
| SD GlucoNFC Blood Glucose | |||||||||
| Monitoring System | Subject Device | ||||||||
| K151265 | |||||||||
| SD GlucoNFC Multi Blood | |||||||||
| Glucose Monitoring System | Predicate Device | ||||||||
| K123517 | |||||||||
| SD GlucoMentor™ BGMS | Predicate Device | ||||||||
| K123517 | |||||||||
| SD GlucoMentor™ Multi | |||||||||
| BGMS | Discussion of | ||||||||
| Differences | |||||||||
| Battery Life | Approximately 1,000 Tests | ||||||||
| Test Strip | |||||||||
| Technology | Glucose Dehydrogenase (GDH) | Glucose Oxidase (GOD) | different | ||||||
| Test Principle | Electrochemical biosensor | ||||||||
| Sample Application | Test strip capillary draw | ||||||||
| Calibration | Plasma-calibrated | ||||||||
| Test Strip Storage | |||||||||
| Conditions | Temperature 2-32°C(36-90°F) | ||||||||
| PC link Feature | Yes, USB Cable or NFC Reader/Writer | Yes, USB Cable | equivalent | ||||||
| Smart device link | |||||||||
| Feature | 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.
9
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.