The U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the U-RIGHT TD-4238 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Description

The kit of U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available (510(k) cleared) lancing device and sterile Lancets, User Manual, and Storage Pack.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the U-RIGHT TD-4238 and TD-4246 Blood Glucose Monitoring Systems:

The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against specific acceptance criteria with a detailed study report. Therefore, much of the requested information regarding specific study details (sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, ground truth for training data) is not explicitly stated within the provided document.

However, I can extract what is present and highlight what is missing based on your request.

Acceptance Criteria and Reported Device Performance

The core claim here is substantial equivalence to the predicate device, not meeting predefined acceptance criteria for a novel device. The document states:

"A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent."

And, "U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System have the same performance characteristics as the predicate device."

Since the specific acceptance criteria and performance of the predicate device are not detailed here, it's impossible to create a table of acceptance criteria vs. specific reported device performance. The implication is that the new device meets the same performance characteristics as the predicate.

Missing Information: Specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) and the detailed results of the U-RIGHT TD-4238/TD-4246 systems against those criteria.

Study Details

Here's a breakdown of the study details based on the provided text, and identification of missing information:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as specific numerical targets for the U-RIGHT devices. The acceptance criterion is "substantial equivalence" to the predicate device (FORA G30/TD-4241). Implied acceptance is that the device demonstrates "the same performance characteristics" as the predicate.
- Reported Device Performance: Not explicitly enumerated in a table. The document only states that performance "demonstrated" substantial equivalence and "have the same performance characteristics" as the predicate device.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Studies for medical devices of this type are typically prospective, but this is not confirmed here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves "human readers." Its purpose is direct measurement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The general performance characteristics (accuracy) of the U-RIGHT system itself would have been tested in a "standalone" fashion to demonstrate equivalence to the predicate. The statement "Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are equivalent to the predicate device" implies standalone testing of the system as a whole. However, explicit details of this testing are absent.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For blood glucose meters, the "ground truth" is typically established by laboratory reference methods (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or similar, which are highly accurate and precise methods for measuring glucose in blood samples). This is not explicitly stated but is the standard for such devices.
The sample size for the training set:
- Sample Size (Training Set): Not specified. The document indicates a "modification in the software of the glucose meter," which might imply some level of software development and possibly associated data for the software. However, it does not detail a separate "training set" in the context of an AI/machine learning model, which is typically what that term refers to. Given this is an electrochemical biosensor, the "training" may be more akin to calibration and optimization data rather than an AI training set.
How the ground truth for the training set was established:
- Ground Truth (Training Set): Not specified. (See point 8 regarding the nature of "training" for this type of device).

Summary of what is explicitly stated:

Device Type: Blood Glucose Monitoring System.
Comparison: Substantial equivalence to FORA G30/TD-4241 Blood Glucose Monitoring System (K090187).
Performance Claim: The new devices "have the same performance characteristics" as the predicate and "demonstrated that they are substantially equivalent."
Technology: Electrochemical biosensor technology using glucose oxidase.
Key changes from predicate: Software modification, physical appearance modification, labeling change.
Software V&V: Software verification and validation confirmed performance, safety, and effectiveness are equivalent to the predicate.

Key Missing Information (as per your request, and typical information found in detailed study reports):

Detailed numerical acceptance criteria.
Specific accuracy, precision, or bias results for the U-RIGHT devices.
Exact sample sizes for any performance evaluation studies.
Details on expert involvement or adjudication.
Any mention of separate "training" and "test" sets in the context of advanced algorithms, although this might not be relevant for a non-AI electrochemical biosensor.
The exact reference method used as ground truth.

Summary

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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 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Debra Liang Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1196 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw

Date of submission: 09/17/2009

1. Device name:
  Proprietary name: U-RIGHT TD-4238 Blood Glucose Monitoring System and U-RIGHT TD-4246 Blood Glucose Monitoring System

Regulatory information:

A. Regulation section: 21 CFR 862.1345 Glucose Test System
B. Classification: Class II
CGA, Glucose Oxidase, Glucose Product Code: C. . NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Chemistry (75)

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3. Intended Use:

4. Device Description:

5. Substantial Equivalence Information:

Predicate device name: A. FORA G30/TD-4241 Blood Glucose Monitoring System

Predicate K number: K090187 B.

Comparison with predicate: ﺯ

The modified U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System have the following similarities to the predicate device:

same operating principle,
. same fundamental scientific technology,
incorporate the same basic circuit design,
incorporate the same materials,
. same shelf life
li packaged using the same materials, and
Manufactured by the same process. I

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The modifications encompass:

. A modification in the software of the glucose meter
Modification in the physical appearance ■
Labeling change due to the software modification 용
1. Test Principle:

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

1. Performance Characteristics:
  U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System have the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the U-RIGHT TD-4238 Blood Glucose Monitoring System /U-RIGHT TD-4246 Blood Glucose Monitoring System are substantially equivalent to the predicate FORA G30/TD-4241 Blood Glucose Monitoring System.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAR 0 2 2010

Taidoc Technology Corporation c/o Ms. Debra Liang Regulatory Affairs Specialist 6F, 127, Wugong 2nd RD Wugu Township Taipei County, China (Taiwan) 248

Re: K092902

Trade Name: U-Right TD-4238 Blood Glucose Monitoring System and U-Right TD-4246 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: February 4, 2010 Received: February 4, 2010

Dear Ms. Liang:

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 II (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

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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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

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

Enclosure

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Section 8.1 Indications for Use (TD-4238)

Indications for Use

510(k) Number:

Device Name: U-RIGHT TD-4238 Blood Glucose Monitoring System

Indications for Use:

The U-RIGHT TD-4238 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the U-RIGHT TD-4238 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use __X (21 CFR Part 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 Evaluation and Safety (OIVD)

Signature of Issuer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Ko92902

Page 1 of

Al.1-1 of 1

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Section 8.2 Indications for Use (TD-4246)

Indications for Use

510(k) Number:

Device Name: U-RIGHT TD-4246 Blood Glucose Monitoring System

Indications for Use:

The U-RIGHT TD-4246 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the U-RIGHT TD-4246 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

And/Or

Prescription Use (21 CFR Part 801 Subpart D)

Over the Counter Use _ X (21 CFR Part 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 Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 10 0 0 2 2 0 2

Page 2 of 2

A1.2-1 of 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.