FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are 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 FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Description

FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of 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 FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided text does not explicitly state specific acceptance criteria (e.g., accuracy percentages or error ranges) for the glucose monitoring system, nor does it present detailed performance data in a table format.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device and broadly states that the new models "have the same performance characteristics as the predicate device" and that a "comparison of system accuracy performance demonstrated that... [the new models] are substantially equivalent." It also mentions that "a mechanical resistance test showed that the model TD-4253 meet the requirement of EN ISO 15197."

Without specific numerical acceptance criteria from the text, a table cannot be fully constructed.

What we can infer about "acceptance criteria" from the text:

Substantial Equivalence: The primary "acceptance criterion" appears to be demonstrating substantial equivalence in performance to an existing, legally marketed predicate device (K082482). This implies that if the predicate device met certain performance standards, the new device must meet or exceed those to be considered substantially equivalent.
Mechanical Resistance: For model TD-4253, meeting the requirements of EN ISO 15197 for mechanical resistance is an acceptance criterion.
Software Verification & Validation: The software's performance, safety, and effectiveness being equivalent to the predicate device is an acceptance criterion.

Reported Device Performance (as stated in the document):

"The FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring Systems have the same performance characteristics as the predicate device."
"A comparison of system accuracy performance demonstrated that the FORA TD-4251 //U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... and the currently marketed FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System are substantially equivalent."
"A mechanical resistance test showed that the model TD-4253 meet the requirement of EN ISO 15197."
"Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... are equivalent to the predicate device."

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

The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "A comparison of system accuracy performance" and "Software verification and validation testing," without providing details on the number of subjects, samples, or how the data was collected for these tests.

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

The document does not mention the use of experts or their qualifications for establishing ground truth for any test set. The nature of a blood glucose monitoring system typically relies on a laboratory reference method (e.g., YSI analyzer) as the ground truth, rather than expert consensus on interpretive tasks.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1 or 3+1. This is expected given that the device measures a quantitative value (blood glucose) and typically compares it against a reference standard, not against human interpretation that might require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Blood glucose monitoring systems are standalone diagnostic devices for quantitative measurement, and their evaluation typically does not involve comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance assessment was implicitly done. The document states:

"A comparison of system accuracy performance demonstrated that the FORA TD-4251 //U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... and the currently marketed FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System are substantially equivalent."
"Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System... are equivalent to the predicate device."

While explicit results are not detailed, these statements confirm that the device's performance was evaluated on its own ("standalone") and compared against a predicate, implying its ability to accurately measure glucose without a human in the loop for the measurement itself (though a human interprets the result).

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for blood glucose monitoring systems, the standard ground truth is typically a laboratory reference method, such as a YSI glucose analyzer, which provides a highly accurate and precise measurement of blood glucose.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is likely because the device is a re-submission of a modified existing device, and the changes are primarily in software and physical appearance, rather than a completely new algorithm requiring a separate training and validation paradigm in the context of this 510(k) summary. For a de novo AI/ML device, this information would be crucial.

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

As no training set is mentioned, information on how its ground truth was established is not provided in the document.

Summary

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Section 10. 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 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw

Date of submission:

1. Device name:
  Proprietary name: FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A

Regulatory information:

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

CGA, Glucose Oxidase, Glucose C. Product Code: NBW, System, Test, Blood Glucose, Over The Counter Chemistry (75) D. Panel:

1. Intended Use:
  FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254

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DEC 1 0 2009

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No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are 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.

1. Device Description:
  FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control solution, A commercially available (510(k) cleared) lancing device and sterile Lancets, User Manual, and Storage Pack.
1. Substantial Equivalance Information:
  Predicate device name: A. FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System

Predicate K number: K082482 B.

Comparison with predicate: C.

The modified FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A have the following similarities to the predicate device:

same operating principle, ■
same fundamental scientific technology, ■
incorporate the same basic circuit design, ■
미 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:

A modification in the software of the glucose meter I
Modification in the physical appearance ■
Labeling change due to the software modification .

6. Test Principle:

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

1. Performance Characteristics:
  The FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring Systems have the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA TD-4251 //U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A and the currently marketed FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System are substantially equivalent. A mechanical resistance test showed that the model TD-4253 meet the requirement of EN ISO 15197.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are substantially equivalent to the predicate FORA TD-4251/ URIGHT TD-4252 / URIGHT TD-4254 Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

TaiDoc Technology Corporation c/o Debra Liang Regulatory Affairs Specialist 6F, No.127, Wugong 2nd Rd., Wugu Township Taipei County, Taiwan

DEC 1 0 2009

K092099 Re:

Trade/Device Name: FORA TD-4251/U-RIGHT TD-4252/ U-RIGHT TD-4253/ U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: November 11, 2009 Received: November 12, 2009

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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 7 Indications for Use

Indications for Use

K092099 510(k) Number:

Device Name: FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A

Indications for Use:

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)

Division Sign-off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 8092090 510(k)

Page I of

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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.