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 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).

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.

AI/ML Overview

The provided text describes information relevant to the submission of the U-RIGHT TD-4116 Blood Glucose Monitoring System and U-RIGHT TD-4116 Pro Blood Glucose Monitoring System to the FDA. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with all the requested information. The document is a 510(k) summary, which typically provides an overview of the device and its performance but not the full study details.

Based only on the provided text, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document mentions that "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." However, it does not explicitly state the acceptance criteria (e.g., ISO 15197 requirements for accuracy) or provide a table of reported device performance against those criteria. It only states that the device was compared to a YSI 2300 Glucose Analyzer.

Missing:

Specific quantitative acceptance criteria (e.g., ISO 15197 accuracy percentages).
Detailed reported device performance data (e.g., bias, % accuracy within certain ranges) against those criteria.

2. Sample size used for the test set and the data provenance:

The document states that "Clinical and Non-clinical studies were conducted," but it does not specify the sample size used for the test set in either study. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the studies).

Missing:

Sample size for clinical and non-clinical test sets.
Country of origin of the data.
Whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions that the devices are compared to a "YSI 2300 Glucose Analyzer" which is "calibrated with NIST (SRM) 917A reference material" for "Traceability." This indicates that the YSI 2300, a laboratory reference method, served as the ground truth. This type of ground truth typically relies on instrumental accuracy and calibration standards, not on human experts adjudicating results.

Missing / Not Applicable:

This question is largely not applicable as the ground truth is an instrumental reference method (YSI 2300) rather than expert interpretation. Therefore, there are no "experts" in the traditional sense involved in establishing the ground truth for a glucose test system.

4. Adjudication method for the test set:

As mentioned above, the ground truth is established by a reference instrument (YSI 2300 Glucose Analyzer). Therefore, no human adjudication method (like 2+1 or 3+1) would be applicable or described for this type of device performance evaluation.

Missing / Not Applicable:

Human adjudication methods are not applicable here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is a blood glucose monitoring system, which is a diagnostic device for quantitative measurement of glucose. It is not an imaging device or an AI-assisted diagnostic tool that involves human "readers" or "cases" in the MRMC sense. Therefore, this type of study is not applicable to the device described.

Not Applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The performance evaluation described is for the device (meter + test strips) operating as a standalone system to measure glucose. While not explicitly termed "standalone algorithm performance," the comparison to the YSI 2300 inherently evaluates the device's accuracy without human interpretation influencing the measurement itself. The "human-in-the-loop" for this device would be the user performing the test, but the accuracy assessment itself focuses on the device's technical measurement capability.

Yes, implicitly. The clinical and non-clinical studies evaluate the device's ability to accurately measure blood glucose compared to a reference method, which is a standalone performance assessment of the device's measurement function.

7. The type of ground truth used:

The ground truth used is an instrumental reference method: the "YSI 2300 Glucose Analyzer," which is calibrated with "NIST (SRM) 917A reference material."

8. The sample size for the training set:

The document does not mention any training set or details about how the device's internal algorithms might have been developed or trained. This type of information is generally not included in a 510(k) summary for a blood glucose meter, as they are typically electrochemical systems rather than machine learning algorithms requiring a distinct "training set."

Missing / Not Applicable.

9. How the ground truth for the training set was established:

Since no training set information is provided or implied, there is no information on how its ground truth was established.

Missing / Not Applicable.

Summary

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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.

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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/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)

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."

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Indications for Use

510(k) Number (if known) K151100

Device Name

U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

Indications for Use (Describe)

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.

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."

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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: _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 TaipeiCity, 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 SystemU-RIGHT TD-4116 Pro Blood Glucose Monitoring System
Common Name:	Blood Glucose Monitoring System
Product Code:	NBW, Blood Glucose Test System, Over-the-CounterCGA, 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

1. Intended Use

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U-RIGHT TD-4116 Blood Glucose Monitoring System:

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:

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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, calfand thigh	Palm, forearm and upper arm
Strip vial opened usetime	3 months	6 months

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Item	Predicate device	Proposed device
Operating condition	50°F - 104°F (10°C-40°C)	Same as predicate
Storage/Transportationcondition	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.

1. 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.
1. 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.
1. 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.

Regulation Number and Section

§ 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.