(233 days)
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No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is a quantitative measurement system for blood glucose and is intended for diagnosis, screening, or monitoring, not for therapy itself.
Yes
The "Intended Use" section states, "The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger... as an aid to monitor the effectiveness of diabetes control." This indicates it provides measurements that aid in managing a medical condition, which is a diagnostic purpose. However, it explicitly states it "should not be used for the diagnosis of or screening for diabetes," which implies it is not for initial diagnosis, but rather for monitoring, which is still a diagnostic aid.
No
The device description explicitly states the system consists of a "blood glucose meter, test strips and mobile platform". The blood glucose meter and test strips are hardware components, making this a system that includes hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Smart Dongle Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being used for diagnostic purposes outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is intended to be used by a single person and should not be shared. Smart Dongle Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JOP
Device Description
The system consists of blood glucose meter, test strips and mobile platform (as a display of the system). And, the blood glucose meter is compatible to iPhone series, including iPhone 4, iPhone 4s, iPhone 5, iPhone 5s, iPhone 6, iPhone 6 plus, iPhone 6s plus. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Smart Dongle Blood Glucose Test Strips can be used only with the Smart Dongle Blood Glucose Monitoring System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger
Indicated Patient Age Range
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Intended User / Care Setting
single person, for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical and non-clinical studies were conducted to tested, verified and validated with respect to the predicate device to establish the performance of the Smart Blood Glucose Monitoring System. The data demonstrates that the Smart Dongle Blood Glucose Monitoring System is substantially equivalent to the predicate devices.
Accuracy:
Results for glucose concentration =75 mg/dL
Within 5%: 57/110 (51.8%)
Within 10 %: 105/110 (95.5%)
Within 15 %: 110/110 (100%)
Within 20 %: 110/110 (100%)
Precision:
Intermediate precision
Control solutions:
Level 1: Mean (mg/dL) 49.6, SD (mg/dL) 2.17, CV (%) 4.38%
Level 2: Mean (mg/dL) 139.4, SD (mg/dL) 4.37, CV (%) 3.13%
Level 3: Mean (mg/dL) 335.4, SD (mg/dL) 10.10, CV (%) 3.01%
Repeatability
Blood samples:
Level 1: Mean (mg/dL) 49.7, SD (mg/dL) 2.18, CV (%) 4.39%
Level 2: Mean (mg/dL) 91.2, SD (mg/dL) 2.95, CV (%) 3.23%
Level 3: Mean (mg/dL) 128.3, SD (mg/dL) 4.06, CV (%) 3.16%
Level 4: Mean (mg/dL) 227.8, SD (mg/dL) 7.18, CV (%) 3.15%
Level 5: Mean (mg/dL) 390.2, SD (mg/dL) 12.06, CV (%) 3.09%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Within 5 mg/dL, Within 10 mg/dL, Within 15 mg/dL, Within 5%, Within 10 %, Within 15 %, Within 20 %
Precision: Mean (mg/dL), SD (mg/dL), CV (%)
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.
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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).
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§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
TAIDOC TECHNOLOGY CORPORATION PAUL LIU, REGULATORY AFFAIRS SPECIALIST B1-7F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT NEW TAIPEI CITY 24888, TAIWAN
Re: K162382
Trade/Device Name: Smart Dongle Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR. JOP Dated: February 23, 2017 Received: February 27, 2017
Dear Paul Liu:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/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,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162382
Device Name
Smart Dongle Blood Glucose Monitoring System
Indications for Use (Describe)
The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is intended to be used by a single person and should not be shared. Smart Dongle Blood Glucose Monitoring System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
| 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)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: _ K162382 _
1. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Paul Liu |
| Title: | Senior Regulatory Affairs Specialist |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, |
| 24888, Taiwan | |
| Phone: | +886-2-6625-8188 |
| Fax: | +886-2-6625-0288 |
| E-mail: | paul@taidoc.com.tw |
| Prepared Date: | Apr. 11th, 2016 |
2. Device name:
| Proprietary Name: | Smart Dongle Blood Glucose Monitoring System |
|---|---|
| Common Name: | Blood Glucose Monitoring System |
| Product Code: | NBW, Blood Glucose Test System, Over-the-Counter |
| LFR, Glucose Dehydrogenase | |
| JQP, Calculator/Data Processing Module | |
| Classification Panel: | Clinical chemistry |
| Classification: | Class II |
| Class I, exempt | |
| Regulation Citation: | 21 CFR §862.1345 |
| 21 CFR §862.2100 |
3. Predicate Device
U-RIGHT TD-4279 blood glucose monitoring system (K101509)
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4. Intended Use
The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single use Smart Dongle test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is intended to be used by a single person and should not be shared. Smart Dongle Blood Glucose Monitoring System 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. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
ട്. Device Description:
The system consists of blood glucose meter, test strips and mobile platform (as a display of the system). And, the blood glucose meter is compatible to iPhone series, including iPhone 4, iPhone 4s, iPhone 5, iPhone 5s, iPhone 6, iPhone 6 plus, iPhone 6s plus. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Smart Dongle Blood Glucose Test Strips can be used only with the Smart Dongle Blood Glucose Monitoring System.
| Item | Proposed device | Predicate device |
|---|---|---|
| Brand Name | Smart Dongle Blood Glucose | |
| Monitoring System | U-RIGHT TD-4279 blood glucose | |
| monitoring system (K101509) | ||
| Intended Use | In the quantitative measurement of | |
| glucose in fresh capillary whole blood | ||
| from the finger | In the quantitative measurement of | |
| glucose in fresh capillary and venous | ||
| whole blood | ||
| Assay method | Same as Predicate | Glucose dehydrogenase biosensor |
| Measuring range | Same as Predicate | 20-600 mg/dL |
| Sample type | Capillary finger stick | Capillary finger stick and Venous |
| whole blood | ||
| Sample size | 1.0 uL | 1.1 uL |
| Hematocrit range | Same as Predicate | 20 % – 70 % |
| Analysis time | Same as Predicate | 5 sec |
Comparison to the Predicate: 6.
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| Coding | No coding | Code strip |
|---|---|---|
| Operating conditions | Same as Predicate | 10 °C – 40 °C, 10% – 85% R.H. |
| Power source | Powered by mobile platform | Two AAA batteries |
| Display | Displayed on mobile platform: | |
| iPhone 4, iPhone 4s, iPhone 5, iPhone 5s, | ||
| iPhone 6, iPhone 6 plus, iPhone 6s, | ||
| iPhone 6s plus and iPod touch 5th generation | LCD display | |
| Data storage | Results stored in the mobile platform | Results stored in the device |
| Data transmission | Headphone port jack | Data cable |
7. Test Principle:
The blood glucose is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter utilizes the current signal to calculate the blood glucose level.
Performance Characteristics: 8.
Clinical and non-clinical studies were conducted to tested, verified and validated with respect to the predicate device to establish the performance of the Smart Blood Glucose Monitoring System. The data demonstrates that the Smart Dongle Blood Glucose Monitoring System is substantially equivalent to the predicate devices.
Accuracy
Results for glucose concentration