(158 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
Explanation: The device is a blood glucose monitoring system used for quantitative measurement of glucose, aiding in monitoring diabetes control, not for direct treatment or therapy.
Yes
The text explicitly states "The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)" and "The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)".
No
The device description explicitly states that the system consists of a blood glucose meter and test strips, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- "The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings..."
This clearly indicates that the device is intended for use outside of the body to diagnose or monitor a condition, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-RIGHT TD-4116 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. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by professionals testing with capillary whole blood samples. The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings 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. The system is only used with single-use, auto-disabling lancing devices. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
Product codes
NBW, CGA
Device Description
The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. And, use only U-RIGHT TD-4116 test strips with the U-RIGHT TD-4116 Blood Glucose Monitoring System. Use only U-RIGHT TD-4116 Pro test strips with the U-RIGHT TD-4116 Pro Blood Glucose Monitoring System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger and alternative sites (palm, forearm and upper arm)
Indicated Patient Age Range
Not for use on neonates.
Intended User / Care Setting
U-RIGHT TD-4116 Blood Glucose Monitoring System: by a single person (people with diabetes) at home.
U-RIGHT TD-4116 Pro Blood Glucose Monitoring System: by professionals (health care professionals) in clinical 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)
Clinical and Non-clinical studies were conducted to evaluate the performance of the modified device. The data from these studies demonstrates that the proposed device is substantially equivalent to the predicate device.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2015
TAIDOC TECHNOLOGY CORPORATION PAUL LIU REGULATORY AFFAIRS SPECIALIST B1-7F, NO.127, WUGONG 2ND RD., WUGU DISTRICT NEW TAIPEI CITY 24888, TAIWAN
Re: K151100
Trade/Device Name: U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, CGA Dated: August 27, 2015 Received: August 31, 2015
Dear Mr. 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.
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 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) K151100
Device Name
U-RIGHT TD-4116 Blood Glucose Monitoring System
Indications for Use (Describe)
The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-RIGHT TD-4116 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. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
| 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
Indications for Use
510(k) Number (if known) K151100
Device Name
U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
Indications for Use (Describe)
The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by professionals testing with capillary whole blood samples. The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for use on neonates. The system is only used with single-use, auto-disabling lancing devices. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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."
4
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: _K151100
1. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Paul Liu |
| Title: | 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: | September 28th, 2015 |
2. Device name:
| Proprietary Name: | U-RIGHT TD-4116 Blood Glucose Monitoring System
U-RIGHT TD-4116 Pro Blood Glucose Monitoring System |
|-----------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Glucose Monitoring System |
| Product Code: | NBW, Blood Glucose Test System, Over-the-Counter
CGA, Glucose Oxidase |
| Classification Panel: | Clinical chemistry |
| Classification: | Class II |
| Regulation Citation: | 21 CFR §862.1345, Glucose test system |
3. Predicate Device
| Proprietary Name: | U-RIGHT TD-4227 No Coding Blood Glucose Monitoring | |||||
|---|---|---|---|---|---|---|
| System | ||||||
| Common Name: | Blood Glucose Monitoring System | |||||
| 510(k) Number: | K090188 |
-
- Intended Use
5
U-RIGHT TD-4116 Blood Glucose Monitoring System:
The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-RIGHT TD-4116 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. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
U-RIGHT TD-4116 Pro Blood Glucose Monitoring System:
The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by professionals testing with capillary whole blood samples. The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings 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. The system is only used with single-use, auto-disabling lancing devices. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).
5. Device Description:
The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. And, use only U-RIGHT TD-4116 test strips with the U-RIGHT TD-4116 Blood Glucose Monitoring System. Use only U-RIGHT TD-4116 Pro test strips with the U-RIGHT TD-4116 Pro Blood Glucose Monitoring System.
6
Comparison to the Predicate: 6.
Comparison of Blood Glucose Meters
| Item | Predicate device | Proposed device |
|---|---|---|
| Code calibration | No coding | Same as predicate |
| Measurement unit | mg/dL | Same as predicate |
| Measurement mode | General and QC (quality control) | General, AC, PC and QC (quality control) |
| Communication | Interface cable | Same as predicate |
| Power source | Two 1.5V AAA batteries | One 1.5V AAA battery |
| Memory Capacity | 450 Memory Sets | Same as predicate |
| Time to Power saving | 180 Seconds | Same as predicate |
| Daily Alarm | No Daily Alarm | 4# Daily Alarm |
| Speaking function | Yes | No |
| Time to Power saving | 180 Seconds | Same as predicate |
| Meter Storage | ||
| /Transportation condition | -4°F - 140°F (-20°C - 60°C) | Same as predicate |
| Dimensions (mm): | 96mm(L) x 45mm(W) x 23mm(H) | 89mm(L) x 52mm(W) x 17mm(H) |
| Weight(g) | 71g without Battery | 47g without Battery |
Comparison of Test Strips
| Item | Predicate device | Proposed device |
|---|---|---|
| Enzyme | Glucose oxidase | Same as predicate |
| Sample volume | 0.7 µL | Same as predicate |
| Reaction time | 7 seconds | Same as predicate |
| Measurement method | Amperometric biosensor | Same as predicate |
| Measuring range | 20-600 mg/dL | Same as predicate |
| Hematocrit range | 20 - 60 % | Same as predicate |
| Sample type | Capillary whole blood | Same as predicate |
| AST | Palm, forearm, upper-arm, calf | |
| and thigh | Palm, forearm and upper arm | |
| Strip vial opened use | ||
| time | 3 months | 6 months |
7
| Item | Predicate device | Proposed device |
|---|---|---|
| Operating condition | 50°F - 104°F (10°C-40°C) | Same as predicate |
| Storage/Transportation | ||
| condition | 50°F - 104°F (10°C-40°C) | Same as predicate |
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:
Clinical and Non-clinical studies were conducted to evaluate the performance of the modified device. The data from these studies demonstrates that the proposed device is substantially equivalent to the predicate device.
- Performance Characteristics:
-
- Traceability:
U-RIGHT TD-4116 Blood Glucose Monitoring System and U-RIGHT TD-4116 Pro Blood Glucose Monitoring System are compared to the YSI 2300 Glucose Analyzer in the clinical and non-clinical studies. The YSI is calibrated with NIST (SRM) 917A reference material.
- Traceability:
-
- Conclusion:
Based on the information provided in this submission, the U-RIGHT TD-4116 Blood Glucose Monitoring System and U-RIGHT TD-4116 Pro Blood Glucose Monitoring System are substantially equivalent to the predicate U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System.
- Conclusion: