The FORA GD43 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).

The FORA GD43 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. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

The FORA GD43 Test Strips are for use with the FORA GD43 Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm).

Device Description

The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA GD43 test strips with the FORA GD43 Blood Glucose Monitoring System.

AI/ML Overview

The provided text describes the FORA GD43 Blood Glucose Monitoring System and its performance studies. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO 15197:2003, for self-testing BGMS)	Reported Device Performance (FORA GD43)
>95% of individual glucose results fall within ±15 mg/dL for glucose concentrations < 75 mg/dL	>95% of individual glucose results fall within ±15 mg/dL for glucose concentrations < 75 mg/dL
>95% of individual glucose results fall within ±15% for glucose concentrations ≥ 75 mg/dL	>95% of individual glucose results fall within ±15% for glucose concentrations ≥ 75 mg/dL
CV (%) less than 5% for intermediate precision	CV (%) less than 5%
CV (%) less than 5% for repeatability	CV (%) less than 5%

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

The document does not explicitly state the exact sample size for the "test set" in terms of number of patients or samples. It only mentions that "Clinical and non-clinical studies were conducted".
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be prospective clinical and non-clinical studies for regulatory submission.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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:

This is a blood glucose monitoring system, not an AI-based diagnostic imaging or interpretive device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers and AI assistance is not applicable and was not done.

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

The device itself is a standalone algorithm (meter) for measuring blood glucose. The performance described is the standalone performance of the FORA GD43 system compared to a reference method (YSI 2300 Glucose Analyzer). There isn't a "human-in-the-loop" component in the algorithm's performance measurement as described for this type of device.

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

The ground truth for the clinical and non-clinical studies was established by comparison to the YSI 2300 Glucose Analyzer. The YSI is a laboratory reference instrument often used as a gold standard for glucose measurement.

8. The sample size for the training set:

The document does not mention a separate "training set" or its sample size. For blood glucose meters, the performance validation typically involves comprehensive testing against a reference method rather than a distinct training/testing split in the conventional machine learning sense.

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

As no separate training set is explicitly mentioned, this question is not directly applicable. However, the document states that the YSI 2300 Glucose Analyzer was calibrated with NIST (SRM) 917A reference material. This indicates the traceability and establishment of the reference standard for all measurements.

Summary

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May 7, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

TAIDOC TECHNOLOGY CORPORATION PAUL LIU REGULATORY AFFAIRS SPECIALIST B1-7F, NO.127, WUGONG 2ND RD., WUGU DISTRICT NEW TAIPEI CITY 24888 TAIWAN

Re: K143467

Trade/Device Name: FORA GD43 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: March 31, 2015 Received: April 2, 2015

Dear Mr. Paul Liu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143467

Device Name

FORA GD43 Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: K143467

1. Submitter Information

Company Name:	TaiDoc Technology Corporation
Contact Person:	Paul Liu
Title:	Regulatory Affairs Specialist
Address:	B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City,
	24888, Taiwan
Phone:	+886-2-6625-8188
Fax:	+886-2-6625-0288
E-mail:	paul@taidoc.com.tw
Prepared Date:	May 4th, 2015

2. Device name:

Proprietary Name:	FORA GD43 Blood Glucose Monitoring System
Common Name:	Blood Glucose Monitoring System
Product Code:	NBW, Blood Glucose Test System, Over-the-CounterLFR, Glucose Dehydrogenase
Classification Panel:	Clinical chemistry
Classification:	Class II
Regulation Citation:	21 CFR §862.1345, Glucose test system

3. Predicate Device

Proprietary Name:	FORA GD40 Blood Glucose Monitoring System
Common Name:	Blood Glucose Monitoring System
510(k) Number:	K101509

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4. Intended Use

5. Device Description:

6. Comparison to the Predicate:

The modified FORA GD43 Blood Glucose Monitoring System has the following similarities to the predicate device:

. Same operating principle.
. Same functions and physical appearance.
Same fundamental scientific technology.
Same user interface. ●

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The modifications:

The material of test strip electrode is changed
. The sample volume required is changed
1. Test Principle:

The blood glucose is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter utilizes the current signal to calculate the blood glucose level.

1. Performance Characteristics:
  Clinical and non-clinical studies were conducted to tested, verified and validated with respect to the predicate device to establish the performance of the FORA GD43 Blood Glucose Monitoring System. More than 95% of the individual glucose results fall within 15 mg/dL at glucose concentrations < 75 mg/dL and within + 15 % at glucose concentrations ≥ 75 mg/dL. The CV (%) is less than 5% both in intermediate precision and repeatability. The data demonstrates that the FORA GD43 Blood Glucose Monitoring System is substantially equivalent to the predicate device.
Traceability: 9.
FORA GD43 Blood Glucose Monitoring System is compared to the YSI 2300 Glucose Analyzer in the clinical and non-clinical studies. The YSI is calibrated with NIST (SRM) 917A reference material.

10. Conclusion:

Based on the information provided in this submission, the FORA GD43 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA GD40 Blood Glucose Monitoring System.

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.