The ForaCare GD20 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from the finger, palm, forearm and upper arm.). It is intended for use by a single person and should not be shared.

The ForaCare GD20 Blood Glucose Monitoring System is intended for self-testing use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes, or for testing of neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The ForaCare GD20 test strips are for use with the ForaCare GD20 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.

Device Description

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ForaCare GD20 Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the ForaCare GD20 Blood Glucose Monitoring System meets the minimum acceptable accuracy required by EN ISO 15197 and the recommendation of FDA guidance for both clinical accuracy with capillary blood from the fingertip and consumer performance.

Acceptance Criteria	Reported Device Performance (ForaCare GD20)
Minimum acceptable accuracy required by EN ISO 15197	Met
Recommendation of FDA guidance	Met

Note: The specific numerical targets for accuracy (e.g., within X% of reference method, or Y% of results within specific zones) for EN ISO 15197 or FDA guidance are not detailed in this summary. It only states that the device "met" these requirements.

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

Test Set Sample Size: Not explicitly stated for either the "Clinical Accuracy study with capillary blood from the fingertip" or the "Consumer Performance Study."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study abstract refers to a "Clinical Accuracy study with capillary blood from the fingertip" and a "Consumer Performance Study," implying they were conducted as part of the validation process, but details on their prospective or retrospective nature are absent.

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

This information is not provided in the given text. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established by laboratory-grade instruments, not human experts in the same way it would be for imaging diagnostics. The text only mentions "Clinical Accuracy study with capillary blood from the fingertip" and "Consumer Performance Study," which would involve comparing the device's readings against a reference method.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods (like 2+1, 3+1) are usually relevant for expert-based assessments (e.g., radiology reads), not typically for quantitative measurements like blood glucose where the ground truth is often from an independent, highly accurate instrument.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This type of study (involving human readers and AI assistance) is for diagnostic imaging or similar applications where human interpretation is a primary component. This device is a blood glucose monitoring system, which performs a direct quantitative measurement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was effectively done. The "Clinical Accuracy study with capillary blood from the fingertip" and "Consumer Performance Study" evaluate the device's (meter + strip) performance in measuring glucose independently against a reference method. While users interact with the device, the core "performance" being assessed is the accuracy of the glucose measurement itself, which is largely an algorithmic/chemical process.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The text implies that the ground truth for glucose measurement was established using a reference method or laboratory-grade instrument. For blood glucose, this typically involves a YSI glucose analyzer or a similar highly accurate laboratory method. The document states "comparison of system accuracy performance," which inherently means comparison to a more accurate reference.

8. The Sample Size for the Training Set:

Not provided. The document describes performance studies (accuracy, precision, consumer studies) but does not detail a separate training set or its size. For a blood glucose monitoring system, the "training" for the device would typically occur during its development and calibration phases, rather than explicitly an "AI training set" in the common sense.

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

Not provided. As with the training set size, the specifics of how the ground truth was established for any internal development/calibration are not mentioned in this regulatory summary.

Summary

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A2. 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: K124040

1. Submitter Information: Application Correspondence: Contact Person: Pinjung Chen Address: 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan Phone: +886-2-6625-8188 #1176 Fax: +886-2-6625-0868 Email: pinjung.chen@taidoc.com.tw
  Date of submission: Dec 21, 2012

Applicant (the 510(k) Owner):

Company Name: FORA Care Inc. Contact Person: Sophia Wu Address: 810 Lawrence Drive, Suite104, Newbury Park, CA 91320 Phone: (805) 498-8188 Fax: (805) 498-7188 E-mail: sophiawu@foracare.com

Device name:

Proprietary name: ForaCare GD20 Blood Glucose Monitoring System

Regulatory information:

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

Product Code: LFR, Glucose Dehydrogenase, Glucose C.

NBW, System, Test, Blood Glucose, Over The Counter

A2- page 1 of 4

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Chemistry (75) D. Panel:

1. Intended Use:
  The ForaCare GD20 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from the finger, palm, forearm and upper arm.). It is intended for use by a single person and should not be shared.

1. Device Description:
  The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.

Substantial Equivalence Information:

Predicate device name: U-RIGHT TD-4252 Blood Glucose Monitoring System, A. model TD-4252
Predicate K number: K101631 B.
Comparison with predicate: C.

The modified ForaCare GD20 Blood Glucose Monitoring System has the following similarities to the predicate device:

1 Same operating principle.
Same fundamental scientific technology.
1 Incorporate the same basic circuit design.

A2- page 2 of 4

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트 Incorporate the same materials.
. Same shelf life.
Packaged using the same materials. .
Manufactured by the same process. .

The modifications encompass:

Physical appearance change,
. Data transmission function with RS232
Fix measurement unit to mg/dL 그
Labeling change due to the above modifications. 1
1. Test Principle:

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

6. Performance Characteristics:

ForaCare GD20 Blood Glucose Monitoring has the same performance characteristics as the predicate device.

1) Comparison System Accuracy and Precision

The comparison of system accuracy performance and precision test demonstrate that the ForaCare GD20 Blood Glucose Monitoring System and U-RIGHT TD-4252 Blood Glucose Monitoring System are substantially equivalent.

2) Clinical Accuracy study with capillary blood from the fingertip

ForaCare GD20 Blood Glucose Monitoring System met the minimum acceptable accuracy required by EN ISO 15197 and recommendation of FDA guidance.

3) Consumer Performance Study

ForaCare GD20 Blood Glucose Monitoring System met the minimum acceptable accuracy required by EN ISO 15197 and recommendation of FDA guidance.

4) Human Factors Study of the Data Transmission Feature

The study demonstrates the usability of the data transmission feature and the Fora Health Care System software is easy for lay users in the homecare environment.

5) Bench Testing of the Data Transmission Accuracy

The bench testing demonstrates accuracy (100%) of data transmission from ForaCare GD20 Blood Glucose Monitoring System to Fora Health Care System software.

1. Software Validation Test

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Software verification and validation testing confirmed that the performance, safety and effectiveness of ForaCare GD20 Blood Glucose Monitoring System are equivalent to the predicate device.

7) Cleaning and Disinfection Validation Test

The cleaning and disinfection protocol employed by the systems is validated for the effectiveness of disinfecting HBV, and are robust to cleaning and disinfection procedures after multiple cleaning and disinfection cycles.

7. Conclusion:

Analytical performance testing on the ForaCare GD20 Blood Glucose Monitoring System demonstrated that the device meets the performance requirement for its intended use. The usability testing and data transmission study showed the modified features of the proposed device are safe for intended use for the users. The data demonstrates that ForaCare GD20 Blood Glucose Monitoring System is substantially equivalent to the predicate U-RIGHT TD-4252 Blood Glucose Monitoring System.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

May 16, 2013

Taidoc Technology Corp. C/O Pinjung Chen 6F, NO. 127, WUGONG 2ND RD, WUGU DISTRICT NEW TAIPEI CITY, 24888, TAIWAN

Re: K124040

Trade/Device Name: ForaCare GD20 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: LFR, NBW Dated: April 15, 2013 Received: April 18, 2013

Dear Pinjung Chen:

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 Part 801); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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Page 2— Pinjung Chen

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Courtne電影_as, Ph.D.

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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A3. Indications for Use Form

Indications for Use Form

510(k) Number (if known): K124040

Device Name: ForaCare GD20 Blood Glucose Monitoring System

Indications for Use:

The ForaCare GD20 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from the finger, palm, forearm and upper arm,). It is intended for use by a single person and should not be shared.

Prescription Use (21 CFR Part 801 Subpart D)

AND/OR

Over the Counter Use (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 Diagnostics and Radiologic Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health 510(k) K124040

Page 1 of

8-1 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.