The FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

The alternative site testing in above systems can be used only during steady-state blood glucose conditions.

Device Description

The FORA G72 / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System are designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of 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 whole blood and control solutions.

AI/ML Overview

The provided text describes three blood glucose monitoring systems (FORA G72/TD-4264, FORA G70/TD-4273, and Ultra Trak Active) and asserts their substantial equivalence to a predicate device (CLEVER CHEK TD-4222 No-Code Blood Glucose Monitoring System). However, it does not provide explicit acceptance criteria or detailed study results proving the device meets specific performance metrics.

The text states:

"FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
"The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of systems meets the intended use."

This indicates that performance studies were conducted, but the specific acceptance criteria and the detailed results demonstrating how those criteria were met are not included in this summary.

Given the absence of the requested information in the provided document, I cannot populate the table and answer the study-specific questions fully.

Here's what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
System Accuracy	Not specified in document	"demonstrated that the performance of systems meets the intended use." (Specific metrics like accuracy within a certain percentage or mg/dL are not provided).
Meter Reliability	Not specified in document	"demonstrated that the performance of systems meets the intended use." (Specific metrics are not provided).
Software Verification & Validation	Not specified in document	"demonstrated that the performance of systems meets the intended use." (Specific metrics are not provided).

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

Sample size: Not specified in the document.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.

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

Not applicable/Not specified. For blood glucose monitoring systems, the "ground truth" for accuracy is typically established using a laboratory reference method (e.g., YSI analyzer) rather than expert consensus on interpretations. The document does not detail how the ground truth was established for the "system accuracy" study.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of a blood glucose measurement device, adjudication by experts is not typically part of the accuracy assessment for the primary output (glucose concentration).

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

No MRMC study was done. This is a standalone diagnostic device for measuring glucose, not an AI-assisted diagnostic imaging or interpretation system that would involve human readers.

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

Yes, implicitly. The "System Accuracy" study would assess the standalone performance of the device (meter + strip) against a reference standard. The document states this study was done, but gives no details.

7. The type of ground truth used

Not specified in the document. For blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI glucose analyzer) rather than expert consensus or pathology.

8. The sample size for the training set

Not applicable/Not specified. This device is described as operating on an electrochemical principle with a dry reagent biosensor. While there might be internal calibrations, the concept of a "training set" as understood in machine learning (which explicitly uses algorithms trained on data) is not directly applicable or described for this type of device in the provided summary.

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

Not applicable/Not specified. (See point 8)

Summary

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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: _________k093005

1. Submitter Information
Company name	TaiDoc Technology Corporation
Contact person	Teling Hsu
Address	6F, No. 127, Wugong 2nd Rd,Wugu Township, Taipei County,24888, Taiwan
Phone	(+886-2) 6625-8188 #1176
FAX	(+886-2) 6625-0288
E-mail	teling.hsu@taidoc.com.tw
Date Prepared	September 27th, 2009
2. Name of Device
Proprietary Names	1. FORA G72 Blood Glucose MonitoringSystem / TD-4264 Blood GlucoseMonitoring System2. FORA G70 Blood Glucose MonitoringSystem / TD-4273 Blood GlucoseMonitoring System3. Ultra Trak Active Blood GlucoseMonitoring System
Common Name	Blood Glucose Test System
Classification Name	Class II devices (21 CFR Section 862.1345)
Product Code	NBW / CGA
3. Predicate Device
Trade/Proprietary Name:	CLEVER CHEK TD-4222 No-Code BloodGlucose Monitoring System
Common/Usual Name:	Blood Glucose Test System
Manufacturer	TaiDoc Technology Corporation
510 (k) Number	K090185

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4. Device Description

5. Intended Use

The alternative site testing in above systems can be used only during steady-state blood glucose conditions.

6. Comparison to Predicate Device

The intended use, test principle, and operating technology of FORA G72 / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring Systems are all the same as the predicate device. The only difference between the predicate and proposed devices is in engineering modification.

These systems use amperometry for blood glucose measurement. The test is based on the measurement of electrical current generated by the reaction of glucose with reagents of the test strip.

7. Performance Studies

FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of systems meets the intended use.

. 8. Conclusion

The FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose

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Monitoring Systems demonstrate satisfactory performance and are suitable for the intended use. FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring Systems are substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Taidoc Technology Corp. C/O Teling Hsu 6F, No. 127, Wugong 2nd Rd. Wugu Township Taipei County China (Taiwan) 248

FEB 5 2010

Re: K093005

Trade/Device Name: FORA G72/TD-4264 Blood Glucose Monitoring System, FORA G70/TD-4273 Blood Glucose Monitoring System, Ultra Trak Active Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: December 23, 2009 Received: January 8, 2010

Dear Teling Hsu:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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

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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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Indications for Use

510(k) Number (if known): |(كَ كَ رَ ن 3

Device Name:

FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System

Indications for Use:

The alternative site testing in above systems can be used only during steady-state blood glucose conditions.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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 Devices (OIVD)

Carol C Benaim

Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k)_K093005 Page 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.