The FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.

The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).

Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.

Device Description

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions).

The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (K161738).

AI/ML Overview

The provided text describes the FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System, a device for measuring glucose, beta-hydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood. It is a 510(k) summary, therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study for a novel device.

Based on the provided information, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:

Key Takeaway: The document primarily focuses on non-clinical and clinical "studies" to demonstrate performance characteristics and compare them to predicate devices, rather than a single, large-scale comparative effectiveness study with human readers (MRMC). The "acceptance criteria" are implied by the performance characteristics tested and similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a table within the provided text. Instead, the document discusses "performance criteria were met" and that the device "met design specifications and requirements." The "acceptance criteria" are implied by meeting the established ranges and performance levels comparable to the predicate devices.

However, the "performance" is reported through the summary of testing. Since this is a 510(k) submission, the primary "performance" shown is that the device is substantially equivalent to the predicate devices. The listed similarities and differences in characteristics serve as the de facto "reported device performance."

Performance Characteristic/Acceptance Criterion (Implied)	Device Performance (FORA ADVANCED GD40)	Notes
Glucose Measurement
Intended Use	Same as Predicate: quantitative measurement in fresh capillary whole blood from the finger to monitor effectiveness of diabetes control program. Not for diagnosis/screening.	Demonstrated equivalence.
Setting	Over-the-counter Home use.	Same as Predicate.
Test Range	20 – 600 mg/dL.	Same as Predicate.
Sample Type	Fingertip Capillary whole blood.	Same as Predicate.
Sample Volume	0.9 μl.	Same as Predicate.
Test Time	5 sec.	Same as Predicate.
Calibration	Automatic.	Same as Predicate.
Operating Principle	Enzymatic (Glucose Dehydrogenase).	Same as Predicate.
Data storage	1000 Results with Date/Time.	Same as Predicate.
Weight	71 g.	Same as Predicate.
Non-Clinical Performance (Precision, Linearity, Interference, Flex, Disinfection, Robustness)	Met design specifications and requirements.	Confirmed via design verification and validation testing. Specific numerical results are not provided in this summary.
Clinical Performance (System Accuracy, Operation, Ease of Use)	Confirmed.	Confirmed via user evaluation. Specific numerical results or study methodology (e.g., sample size, metrics) not provided in this summary.
β-Ketone Measurement
Intended Use	Same as Predicate: quantitative measurement in fresh capillary whole blood from the finger to monitor effectiveness of diabetes control program. Not for diagnosis/screening.	Demonstrated equivalence.
Setting	Over-the-counter Home use.	Same as Predicate.
Test Range	20 – 600 mg/dL (same as glucose listed in table, but typical ketone ranges are different, likely copied from glucose for tabular similarity, the actual range for β-Ketone would be specified in detailed report).	Needs clarification as this range is for glucose. β-Ketone measurements are based on B-hydroxybutyrate dehydrogenase. However, the document clearly states the β-Ketone test system is 'Class I, meets the limitations of exemption 21 CFR 862.9(c)(5)', implying minimal testing required for equivalence assuming the core technology (test strips and control solutions) are the same as the predicate (K161738), as stated in Device Description section E.
Non-Clinical Performance	Met design specifications and requirements.	Confirmed via design verification and validation testing. Specific numerical results are not provided in this summary. The glucose/ß-ketone test strips and control solutions are stated to be "the same as the predicate," which simplifies the testing needed to demonstrate substantial equivalence for these analytes.
Clinical Performance	Confirmed.	Confirmed via user evaluation.
Cholesterol Measurement
Intended Use	Same as Predicate: diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism.	Demonstrated equivalence.
Setting	Over-the-counter Home use. (Predicate: Over-the-counter Home use and Prescription use).	Difference noted: Proposed device is only OTC Home use, while predicate was also Prescription use. This is a narrowing of intended use, which is generally acceptable for substantial equivalence.
Test Range	100 – 400 mg/dL.	Same as Predicate.
Sample Type	Fingertip Capillary whole blood.	Same as Predicate.
Sample Volume	5 μl. (Predicate: 10 μl)	Difference noted: Lower sample volume on the proposed device. This is typically viewed as an improvement, but would have been supported by specific performance data in the full submission.
Test Time	60 sec. (Predicate: < 2 min)	Difference noted: Faster test time. This is typically viewed as an improvement, supported by specific performance data.
Calibration	Same as Predicate: Calibration strip.	Demonstrated equivalence.
Operating Principle	Enzymatic (Cholesterol esterase to free cholesterol, then oxidized by cholesterol oxidase).	Same as Predicate.
Data storage	1000 Results with Date/Time. (Predicate: 200 Results)	Difference noted: Significantly more data storage. This is an improvement.
Weight	71 g. (Predicate: 145 g)	Difference noted: Significantly lighter. This is an improvement.
Non-Clinical Performance	Met design specifications and requirements.	Confirmed via design verification and validation testing. Specific numerical results for precision, linearity, interference, flex studies, disinfection, cleaning, robustness, and software validation are not provided, but the conclusion states they were met.
Clinical Performance	Confirmed.	Confirmed via user evaluation.
General Device Performance
Electrical/Mechanical Safety	Met specifications.	Confirmed via testing.
Software Validation (Moderate Level of Concern)	Performed and met requirements as per FDA Guidance.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the sample sizes for the "non-clinical" or "clinical" studies. It only states that "Non-clinical and clinical studies were conducted to test, verify and validate the performance."
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter's address (TaiDoc Technology Corporation, New Taipei City, Taiwan), it's highly probable the studies were conducted in Taiwan or involved participants from that region. The studies are described as "verification and validation testing" and "user evaluation," which suggests prospective data collection for the purpose of regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the summary. Since the device is a direct measurement system (glucose, ketone, cholesterol) and relies on chemical reactions rather than interpretation of medical images or complex diagnostic algorithms, the "ground truth" would typically be established by laboratory reference methods, not by expert consensus of clinicians/radiologists.
Therefore, the concept of "experts" in the context of establishing ground truth for this type of device (an in-vitro diagnostic) would refer to the use of highly accurate laboratory equipment and trained laboratory personnel following established protocols, rather than medical specialists.

4. Adjudication Method (for test set)

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (often radiologists) interpret medical images and their interpretations need to be reconciled to establish ground truth or compare to AI performance. For an in-vitro diagnostic device that measures chemical concentrations, the ground truth comes from laboratory reference methods, not subjective human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done (or at least not described in this summary). This type of study is relevant for imaging AI devices where the effect of AI assistance on human reader performance is evaluated.
This device is an in-vitro diagnostic for direct chemical measurement, not an imaging AI. Therefore, an MRMC study is not relevant for demonstrating its performance or substantial equivalence.

6. Standalone (Algorithm Only) Performance

No, not specified as a separate study type in the context of imaging AI.
However, the "Non-Clinical Testing Summary" mentions "functional performance tests (precision, linearity, interference, flex studies)." These are essentially "standalone" performance evaluations of the device's accuracy and robustness under various conditions, independent of a human user's direct interpretive "performance" in the way an AI algorithm's standalone performance might be assessed. The "clinical testing" included a "user evaluation" to confirm accuracy and ease of use in a real-world scenario.

7. Type of Ground Truth Used

The ground truth used for this device would be laboratory reference methods.

The test principle explicitly states that the device is "calibrated to display the equivalent of plasma glucose values to allow comparison of results with laboratory methods."
The non-clinical testing included "precision, linearity, interference, flex studies," all of which require comparison to a highly accurate reference method to establish the true concentration of the analytes (glucose, β-ketone, cholesterol).
For the β-ketone and cholesterol measurements, the process involves enzymatic reactions that are proportional to the amount of the substance in the sample, which implies quantitative comparison to a known concentration.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a traditional in-vitro diagnostic, not a machine learning or AI-based device that would require a "training set" in the sense of AI model development. Its calibration and function are based on electrochemical biosensor technology and established chemical principles.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device's operational parameters would be established through calibration against known standards and validation against reference laboratory methods during its development and manufacturing process.

Summary

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June 16, 2022

TaiDoc Technology Corporation Jacky Chou Director of Regulatory Affairs B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan

Re: K201037

Trade/Device Name: FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JIN, CHH Dated: February 24, 2022 Received: March 1, 2022

Dear Jacky Chou:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201037

Device Name

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

Indications for Use (Describe)

The FORA ADVANCED GD40 Glucose, p-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.

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)
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510(k) Summary

Submission Number: K201037

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter Information

Company Name:	TaiDoc Technology Corporation
Contact Person:	Jacky Chou
Title:	Director of Regulatory Affairs
Address:	B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New TaipeiCity, 24888, Taiwan
Phone:	+886-2-6625-8188
Fax:	+886-2-6625-0288
E-mail:	jacky.chou@taidoc.com.tw
Prepared Date:	June 16th, 2022

B. Regulatory information:

Proprietary Name:	FORA ADVANCED GD40 Glucose, β-Ketone and CholesterolMonitoring System
Product Code:	NBW - Blood Glucose Test System, Over-the-CounterJIN - nitroprusside, ketones (urinary, non-quant.)CHH - enzymatic esterase--oxidase, cholesterol

Classification Panel:	75, Clinical chemistry
Classification:	Class II (glucose test)
	Class I, meets the limitations of exemption 21 CFR 862.9(c)(5) (β-ketone test)
	Class I, meets the limitations of exemption 21 CFR 862.9(c)(4)(cholesterol test)

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Regulation Citation:	21 CFR 862.1345, Glucose test system
	21 CFR 862.1435 Ketones (nonquantitative) test system
	21 CFR 862.1175 Cholesterol (total) test system.

C. Predicate Devices

FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems (K161738)

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406)

D. Indications for Use

The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 ß-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.

The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, betahydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be shared. This device is intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).

Glucose and ß-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.

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E. Device Description:

F. Test Principle:

Glucose measurement is based on electrochemical biosensor technology using the enzyme Glucose Dehydrogenase to catalyze the formation of gluconolactone from the oxidation of glucose whereby two electrons are produced. The electrical current resulting from this enzymatic reaction is measured and correlated to glucose concentration by the meter. The magnitude of the current is proportional to the concentration of glucose in the sample. The test strip is calibrated to display the equivalent of plasma glucose values to allow comparison of results with laboratory methods. Using the same technology, Bhydroxybutyrate (B-ketone) is converted by ß-hydroxybutyrate dehydrogenase and the magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of B-hydroxybutyrate present in the sample; Cholesterol esters in serum are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids, whereby liberated cholesterol, plus any endogenous free cholesterol, are oxidized by cholesterol oxidase and the magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of cholesterol present in the sample.

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G. Summary of Technological Characteristics and Comparison to the Predicate

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

Similarities and Differences: System (Test and Instrument) for blood Glucose and Ketone
Feature orCharacteristic	Predicate: FORA ADVANCEDGD40 Blood Glucose and β-KetoneMonitoring System (K161738)	Candidate: FORA ADVANCEDGD40 Glucose, β-Ketone andCholesterol Monitoring System
Intended Use	It is intended for the quantitativemeasurement of glucose in freshcapillary whole blood from thefinger, and for the quantitativemeasurement of β-ketone (beta-hydroxybutyrate) in fresh capillarywhole blood from the finger. TheFORA ADVANCED GD40 isintended for in vitro diagnostic useand is intended for single-patient useas an aid to monitor the effectivenessof a diabetes control program. Thesystem should not be used for thediagnosis of or screening fordiabetes.	Same
Setting to be used	Over-the-counter Home use	Same
Test Range	20 – 600 mg/dL	Same
Sample Type	Fingertip Capillary whole blood	Same
Sample Volume	0.9 μl	Same
Test Time	5 sec	Same
Calibration	Automatic	Same
OperatingPrinciple	Enzymatic	Same
Data storage	1000 Results with Date/Time	Same
Weight	71 g	Same
Analytes	Glucose and β-Ketone	Glucose, β-Ketone, and Cholesterol

Table 1: Similarities and differences between the predicate and proposed device (Glucose and Ketone)

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	Table 2: Similarities and differences between the predicate and proposed device
(Cholesterol)

Similarities and Differences: System (Test and Instrument) for blood Cholesterol
Feature orCharacteristic	Predicate: Mission CholesterolMonitoring System (K163406)	Candidate: FORA ADVANCEDGD40 Glucose, \u03b2-Ketone andCholesterol Monitoring System
Intended Use	It is intended to be used in thediagnosis and treatment of disordersinvolving excess cholesterol in theblood and lipid and lipoproteinmetabolism disorders. Cholesterolshould be measured at the frequencyrecommended by the healthcareprovider.	Same
Setting to be used	Over-the-counter Home use andPrescription use	Over-the-counter Home use
Test Range	$100 - 400 mg/dL$	Same
Sample Type	Fingertip Capillary whole blood	Same
Sample Volume	$10 \mu l$	$5 \mu l$
Test Time	< 2 min	60 sec
Calibration	Calibration strip	Same
OperatingPrinciple	Enzymatic	Same
Data storage	200 Results with Date/Time	1000 Results with Date/Time
Weight	145 g	71 g

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H. Summary of Testing:

Non-clinical and clinical studies were conducted to test, verify and validate the performance of the proposed device. 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 ADVANCED GD40 Glucose, β-Ketone and Cholesterol 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, and robustness 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.

I. Conclusion:

The results of software validation and performance verification testing confirmed that the FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System is substantially equivalent to that of the predicate devices.

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.