The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for in vitro diagnostic use by 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. It is intended to be used by a single person and should not be shared.

Device Description

The FORA GTel Blood Glucose Monitoring System consists of FORA GTel blood glucose meter and FORA GTel blood glucose test strip which have been designed, tested, and proven to produce accurate blood glucose test result only when used in combination.

AI/ML Overview

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

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Accuracy)	Reported Device Performance (Accuracy)
95% within ± 15%	95% within ± 15%
99% within ± 20%	99% within ± 20%

Note: The document specifies the acceptance criteria as "95% within ± 15%; 99% within ± 20%" under the 'Proposed Device' column for Accuracy in Table 2, but it also lists this as the reported performance, implying the device met these criteria.

Study Information

The provided document summarizes testing, but details regarding certain aspects are limited.

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

Sample Size: Not explicitly stated for either the non-clinical or clinical studies.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be part of the submission to the FDA (U.S.). The submission is for a device from "ForaCare Inc." with an address in Moorpark, CA, USA, and a contact person with phone/fax numbers in both the US and possibly Taiwan (indicated by +886 country code). The studies are summarized to meet FDA guidance.
Retrospective/Prospective: Not explicitly stated. Clinical testing usually implies a prospective study.

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

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Not specified. The ground truth is established by the YSI-2300 Glucose Analyzer.

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, a MRMC study was not done. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone study was done. The "System Accuracy" (95% within ± 15%; 99% within ± 20%) is a measure of the device's performance in comparison to a reference method (YSI-2300 Glucose Analyzer). While a "user evaluation" confirmed system accuracy, the numerical accuracy presented reflects the device's inherent measurement capability.

7. The type of ground truth used

Reference method comparison: The ground truth was established by comparing the FORA GTel Blood Glucose Monitoring System results to those from a YSI-2300 Glucose Analyzer.

8. The sample size for the training set

Training Set Sample Size: Not explicitly mentioned. Blood glucose monitoring systems typically do not have a "training set" in the sense of machine learning algorithms. The performance is validated through non-clinical and clinical studies.

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

Not applicable as there isn't a "training set" in the conventional machine learning sense. The YSI-2300 Glucose Analyzer, calibrated with NIST (SRM) 917A reference material, serves as the reference standard for establishing the accuracy of the device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

August 9, 2018

ForaCare Inc. Anne Kuo Regulatory Affairs Specialist 893 Patriot Dr., Suite D Moorpark, CA 93021

Re: K173505

Trade/Device Name: FORA GTel Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: July 9, 2018 Received: July 10, 2018

Dear Anne Kuo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

Courtney H. Lias, Ph.D. for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173505

Device Name

FORA GTel Blood Glucose Monitoring System

Indications for Use (Describe)

The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Test Strip and the FOR A GTel Blood Glucose meter.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 K173505.

1. Applicant Information

Company	ForaCare Inc.
Address	893 Patriot Dr., Suite D, Moorpark, CA 93021 USA
Phone	1-805-498-8188
Fax	1-805-498-7188
Contact Person	Anne Kuo
Title	Regulatory Affairs Senior Specialist
Phone	+886-2-6625-8188 #1195
Fax	+886-2-6625-0608
E-mail	ra.cert@taidoc.com.tw
	anne.kuo@taidoc.com.tw

2. Proposed Device Information

Proprietary Name	FORA GTel Blood Glucose Monitoring System
Regulation Description	Glucose test system
Review Panel	Clinical Chemistry
Product Code	NBW	Blood Glucose Test System, Over-the-Counter
Regulation Number	21 CFR §862.1345
Device Class	2

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Image /page/4/Picture/0 description: The image shows the logo for ForaCare Inc. The logo is in blue and features the company name in a stylized font. Below the company name is the tagline "The New Leader in Medical Device Technology."

3. Predicate Device Information

Proprietary Name	FORA GD43 Blood Glucose Monitoring System
Regulation Description	Glucose test system
Manufacturer	TaiDoc Technology Corporation
510(k) number	K143467

4. Intended Use:

The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Test Strip and the FORA GTel Blood Glucose meter.

5. Device Description:

6. Test Principle:

The system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

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Image /page/5/Picture/0 description: The image shows the logo for ForaCare Inc. The logo is in blue and features the company name in a stylized font. Below the company name is the tagline "The New Leader in Medical Device Technology."

7. Summary of Technological Characteristics and Comparison to the Predicate

The FORA GTel Blood Glucose Monitoring System is substantially equivalent to the predicate device, both in terms of intended use and technological characteristics.

The similarities and differences between the predicate and proposed devices are summarized in Table 1 and 2 below.

Characteristic	Predicate Device	Proposed Device
Detection method	Amperometric glucose biosensor	Same
Enzyme	Glucose dehydrogenase (GDH)	Same
Electrode material	Gold	Same
Blood volume	0.5 µ1	Same
Reaction time	5 seconds	Same
Measurement range	20~600 mg/dL	Same
Code type	Code Card	Same
Sample type	Capillary whole blood	Same
Ketone warning	no	Same
Glucose warning	No Hi/Lo Indicator	Same
Measurement mode	Gen/AC/PC/QC	Same
Day average	7-, 14-, 21-, 28-, 60- and 90-day	Same
Power saving	Idling for 180 seconds	Same
Alarm clock	4	Same
Memory capacity	1000 measurements	Same
Strip ejector	Yes	Same
Operating condition	46.4 °F~~113 °F (8 °C~~45 °C)	Same
Meter storage condition	-4 °F~~140 °F (-20 °C~~60 °C)	Same
Strip storage condition	35.6°F~~86.0°F (2°C~~30°C)	Same
Characteristic	Predicate Device	Proposed Device
Appearance	Image: Predicate Device	Image: Proposed Device
Dimension (mm)	110 (L) x 57 (W) x 25 (H)	98 (L) x 55 (W) x 15.5 (H)
Weight	71 (without battery)	63.2 (without battery)
Intended use	• for use in the quantitativemeasurement of glucose in freshcapillary whole blood from thefingertip and alternative sites(palm, forearm and upper arm)• for in vitro diagnostic use bypeople with diabetes at home• for single person and should notbe shared• not for the diagnosis of orscreening for diabetes• not for neonates	• for use in the quantitativemeasurement of glucose infresh capillary wholeblood from the finger• for in vitro diagnostic useby people with diabetesmellitus at home• for single person andshould not be shared• not for the diagnosis of orscreening for diabetes• not for neonates
Hematocrit range	20%~70%	20%~60%
Accuracy	$±$ 15 mg/dL if $≤$ 75 mg/dL;$±$ 20 % if $>$ 75 mg/dL	95% within $±$ 15%;99% within $±$ 20%
AST	Yes, Palm, forearm and upper arm	No
Measurement Unit	Fix mg/dL	Either mg/dL or mmol/L(Default mg/dL)
Talking function	No	Yes
LCD type	LCD	TFT LCD
Power source	2 x 1.5V AAA batteries	1 x 3.7V Li-Ionrechargeable battery
Data transmission	RS-232 4 Poles	3G

Table 1: Similarities between the Predicate and Proposed Devices

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Image /page/6/Picture/0 description: The image shows the logo for ForaCare INC. The logo is in blue and features the company name in a stylized font. Below the logo is the tagline "The New Leader in Medical Device Technology."

Table 2: Differences between the Predicate and Proposed Devices

• ForaCare Inc., 893 Patriot Dr., Suite D, Moorpark, CA 93021 USA TEL: 1-805-498-8188 FAX: 1-805-498-7188 •

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8. Summary of Testing

Non-clinical and clinical studies were conducted to test, verify and validate the performance of the proposed device according to FDA Guidance issued on October 11, 2016: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. Results from these studies show that all performance criteria were met.

Non-Clinical Testing Summary: Design verification and validation testing was performed to ensure that the FORA GTel Blood Glucose Monitoring System met design specifications and requirements. Testing activities included electrical/mechanical safety tests, functional performance tests (precision, linearity, interference, flex studies) as well as disinfection, cleaning, robustness, and shelf life studies. Software validation was performed for this moderate level of concern device per FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.

9. Traceability

This 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 GTel Blood Glucose Monitoring System is believed to be substantially equivalent with the predicate device.

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.