FORA G31a/TD-4256A is intended for in vitro 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 testing sites in the FORA G31a/TD-4256A Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.

FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31a/TD-4256A glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.

FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31a/TD-4256A Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

FORA G31b/TD-4256B is intended for in vitro 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 testing sites in the FORA G31b/TD-4256B Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.

FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31b/TD-4256B glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.

FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31b/TD-4256B Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

Device Description

FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System consist of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

AI/ML Overview

The provided text describes the 510(k) summary for the FORA G31a/TD-4256A and FORA G31b/TD-4256B Blood Glucose Monitoring Systems. However, it does not contain the detailed performance study results, acceptance criteria, or most of the specific information requested in the prompt.

The document states: "The performance of FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System was studied in the laboratory. The studies demonstrated that the performance of this system meets its intended use." This is a general statement, but no specific data, acceptance criteria, or study design details are provided.

Therefore, I cannot fulfill most of your request from the given text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

Cannot be provided. The document states that performance studies were conducted and met the intended use, but it does not specify the acceptance criteria (e.g., accuracy percentages, bias limits) or report the actual device performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The sample size for the test set and the data provenance are not mentioned in the document. It only states that "studies were conducted in the laboratory."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. This information is not present in the document. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by experts in the context of diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Adjudication methods are not applicable nor mentioned for this type of device and study.

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

Cannot be provided. MRMC studies are typically for diagnostic imaging devices involving human interpretation. This is a blood glucose meter, and no such study is mentioned or relevant.

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

Cannot be provided directly in the requested format. A blood glucose meter inherently provides a "standalone" reading (the algorithm processes the electrochemical signal to produce a glucose value). However, the document doesn't explicitly describe a study focused on "algorithm only" performance separate from the device's main function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Inferred based on device type: For blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer). This is not explicitly stated in the document but is standard for such devices.

8. The sample size for the training set

Cannot be provided. The document does not mention a training set size. Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do, as their measurement principle is electrochemical.

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

Cannot be provided. As a training set isn't explicitly mentioned or relevant in the context of typical blood glucose meter development (compared to ML-based systems), how its ground truth would be established is not discussed.

Summary of available information related to performance:

The document states that the device's performance was studied in the laboratory and that these studies demonstrated the system meets its intended use. However, no specific details about these studies (e.g., number of participants, specific glucose ranges tested, comparison to reference methods, accuracy metrics, or acceptance criteria) are provided. The information focuses on the device description, intended use, and substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187).

Summary

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K094005

510 (k) Summary

MAY - 5 2010

Submitter Information

Company name TaiDoc Technology Corporation Contact person Nicky Pan Address 6F, No. 127, Wugong 2nd Rd, Wugu Township, Taipei County, 24888. Taiwan Phone (886-2) 6625-8188 FAX (886-2) 6625-0288 E-mail nicky@taidoc.com Date Prepared Dec 23rd, 2009

Name of Device

Trade Names: FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System Common Names/Descriptions Blood Glucose Meter Blood Glucose Test Strips Classification Names Class II devices (21 CFR Section 862.1345, Glucose Test System)

Predicate Device

Trade/Proprietary Name: FORA G30 Blood Glucose Monitoring System (Model TD-4241) Common/Usual Name: Blood Glucose Meter Blood Glucose Test Strips Manufacturer TaiDoc Technology Corporation 510 (k) Number K090187

Device Description

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5. Intended Use

FORA G31a/TD-4256A Blood glucose monitoring system:

FORA G31b/TD-4256B Blood glucose monitoring system:

FORA G31b/TD-4256B is intended for in vitro 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 testing sites in the FORA G31a/TD-4256A Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.

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6. Comparison to Predicate Device

FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System have equivalent technological characteristics as the FORA G30 Blood Glucose Monitoring System (K090187, Model TD-4241). FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System also have the same intended use as the FORA G30 Blood Glucose Monitoring System (Model TD-4241).

7. Performance Studies

The performance of FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System was studied in the laboratory. The studies demonstrated that the performance of this system meets its intended use.

8. Conclusion

FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System demonstrate satisfactory performance and are suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The words are stacked on one line.

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing left and appears to be in flight.

Taidoc Technology Corporation c/o Mr. Nicky Pan Specialist of Regulatory Affairs 6F, No. 127, Wugong 2nd Road, WUGU Township Taipei County, China (Taiwan) 248

JUL - 8 2010

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

K094005 Re:

Trade Name: FORA G31a/TD-4256A Blood glucose monitoring system i FORA G31b/TD-4256B 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 04, 2010 Received: March 01, 2010

Dear Mr. Pan:

This letter corrects our substantially equivalent letter of May 5, 2010.

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 while be 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.

a&untrates.
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 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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,

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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Indications for Use

510(k) Number:K094005

Device Name: FORA G31a/TD-4256A Blood glucose monitoring system

Indications for Use: .

AND/OR Over-The-Counter Use X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Division Sign-C

510kl

Office of In Vitro Diagne Device Evaluation and Safety

Page 1 of 2

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Indications for Use

510(k) Number:K094005

Device Name: FORA G31b/TD-4256B Blood glucose monitoring system

Indications for Use:

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Division Sign-Off

Office of In Vitro Diagno Device Evaluation ar

510(k) K094005

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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.