The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.

The U-RIGHT TD-4280 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contains speaking functions but is not intended for use by visually impaired users.

The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

Device Description

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

AI/ML Overview

Here's an analysis of the provided text regarding the U-RIGHT TD-4280 Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state specific numerical acceptance criteria for the U-RIGHT TD-4280 Blood Glucose Monitoring System. Instead, it relies on demonstrating substantial equivalence to a predicate device (TD-4277 Blood Glucose Monitoring System). The performance characteristic considered for equivalence is "system accuracy performance."

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Equivalence)	Reported Device Performance
System Accuracy	Equivalent to TD-4277 Blood Glucose Monitoring System	Demonstrated equivalence to the predicate device.
Software Performance	Equivalent to TD-4277 Blood Glucose Monitoring System	Software verification and validation confirmed equivalent performance, safety, and effectiveness to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the full study report, which is not included in this 510(k) summary. The summary only mentions "A comparison of system accuracy performance" and "Software verification and validation testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the given text. For a blood glucose monitoring system, the "ground truth" for accuracy studies is typically established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer) performed by trained clinical laboratory personnel, not by medical experts in the sense of radiologists or pathologists.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Adjudication methods are typically relevant for studies where subjective expert review is involved. For a blood glucose meter, the comparison is usually against an objective reference laboratory method, making a traditional adjudication process (like 2+1) less applicable.

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

An MRMC comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic imaging devices where human readers interpret images, often with and without AI assistance, to assess the AI's impact on human performance. The U-RIGHT TD-4280 is a blood glucose monitoring system, directly measuring glucose levels, not assisting human interpretation of complex data.

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

The context of "standalone" performance (algorithm only) is usually discussed for AI/ML-driven diagnostic systems. For a blood glucose meter, the device itself provides the measurement, and its "standalone performance" is what is being evaluated (i.e., how accurately it measures glucose). The entire system (meter + strip) is designed to operate without continuous human-in-the-loop interpretation beyond the user taking the reading. The summary implies the device's accuracy was tested independently.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The exact type of ground truth is not explicitly stated, but for blood glucose monitoring systems, the ground truth is universally established through laboratory reference methods. This would involve comparing the glucose readings from the U-RIGHT TD-4280 system to results obtained from a highly accurate laboratory instrument, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in blood samples.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning algorithms. While the device contains software, the 510(k) summary does not indicate that it uses a machine learning algorithm that requires a separate "training set" in the conventional sense. The device's electrochemical biosensor technology likely relies on pre-defined algorithms and calibration, rather than a learned model from a large training dataset. Therefore, information about a training set sample size is not provided and likely not applicable in the AI/ML context.

9. How the Ground Truth for the Training Set was Established

As noted in point 8, the concept of a "training set" as it relates to AI/ML is likely not applicable here. If the device's internal algorithms required calibration, this would be done against laboratory reference methods to ensure accuracy across the measurement range, similar to how ground truth for performance evaluation is established. However, the document does not detail these developmental and calibration processes.

Summary

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APR 1 2 2012

Section 11. 510(k) Summary

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:

1. Submitter's Identification:
  TaiDoc Technology Corporation

3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan

Correspondent:

Meiru Li

Regulatory Affairs Specialist

Tel: +886-2-6625-8188 #6134

Fax: +886-2-6625-0288

Email: limeiru@taidoc.com.tw

Prepared date: December 19, 2011

1. Device name:
  ்.

Proprietary name: U-RIGHT TD-4280 Blood Glucose Monitoring System

Regulatory information:

Regulation section: 21 CFR 862.1345 Glucose Test System A.
Classification: Class II B.

LFR, Glucose Dehydrogenase, Glucose Product Code:

NBW, System, Test, Blood Glucose, Over the Counter

Clinical Chemistry (75) Panel: D.

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3. Intended Use:

but is not intended for use by visually impaired users.

The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

1. Device Description:
  The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

Substantial Equivalence Information: ડાં

A. Predicate device name: TD-4277 Blood Glucose Monitoring System

Predicate K number: K100322 B.

C. Comparison with predicate:

The modified U-RIGHT TD-4280 Blood Glucose Monitoring System has the following similarities to the predicate device:

트 same operating principle,

same fundamental scientific technology, 1

incorporate the same basic circuit design,

incorporate the same materials,

same shelf life

packaged using the same materials, and

manufactured by the same process.

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The modifications encompass:

Addition of the speaking function
Modification in the physical appearance 트
. Minor software modifications of the glucose meter
1 Change of the data transmission method from USB to RS-232
Reduced the memory capacity from 1000 measurement to 450 measurement 1
Labeling change due to the above modifications 0

· 6. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose dehydrogenase.

7. Performance Characteristics:

U-RIGHT TD-4280 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4280 Blood Glucose Monitoring System and the TD-4277 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4280 Blood Glucose Monitoring System are equivalent to the predicate device. '

8. Conclusion:

Based on the information provided in this submission, the U-RIGHT TD-4280 Blood Glucose Monitoring System is substantially equivalent to the predicate TD-4277 Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the right, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is depicted with flowing lines, giving it a sense of movement. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration

TAIDOC TECHNOLOGY CORPORATION C/O MEIRU LI 6F, NO. 127 WUGONG 2ND RD. WUGU TOWNSHIP NEW TAIPEI CITY CHINA (TAIWAN) 24888

10903 New Hampshire Avenue Silver Spring, MD 20993

APR 1 2 2012

Re: K113768

Trade Name: U-Right TD-4280 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR Dated: March 12, 2012 Received: March 15, 2012

Dear Meiru Li

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.

If your device is classified (see above) into either class Iİ (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N.
Gary K. Haines, Ph.D.

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment E.

Indications for Use

510(k) Number (if known):

Device Name: U-RIGHT TD-4280 Blood Glucose Monitoring System, model TD-4280

Indications for Use:

The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

(Part ) Prescription Use _____________________________________________________________________________________________________________________________________________________________ 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_K1137

Attachment E.- 1

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.