The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

Device Description

The GlucoSure Link blood glucose monitoring system consists of the GlucoSure Link meter, GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution are purchased separately.

The modified device of GlucoSure Link glucose meter is derived from the existing device of AutoSure Voice II meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device and removed the voice Feature.

The glucose test strips and glucose control solution utilized in the GlucoSure Link Blood Glucose Monitoring System are the same as the AutoSure glucose test strips and Contrex Plus Glucose Control Solution, previously cleared in K102037.

The meter materials of GlucoSure Link glucose meter are the same as the AutoSure Voice II meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in K150396.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and the study proving the device meets these criteria in the context of advanced AI-driven medical devices. Instead, it is an FDA 510(k) summary for a blood glucose monitoring system, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific acceptance criteria.

Therefore, I cannot extract the information required by your prompts regarding AI performance metrics, expert consensus, MRMC studies, or training/test set details for an AI model.

However, I can extract information related to the device described in the document, which is a Blood Glucose Monitoring System. Here's what I can provide based on the given text:

Device: GlucoSure Link Blood Glucose Monitoring System

1. A table of acceptance criteria and the reported device performance:

The document mentions "linearity, precision, short sample detection, intermittent sampling, sample perturbation, temperature and humidity testing" as non-clinical testing conducted, and "method comparison and user studies for glucose" as clinical testing. It states that "results demonstrate substantial equivalence to the predicate system," but does not provide specific numerical acceptance criteria or performance metrics in a defined table format. For blood glucose monitoring systems, performance is typically evaluated against standards like ISO 15197, which define accuracy criteria (e.g., percentage of results within a certain deviation from a reference method). These specific numerical criteria and the device's performance against them are not detailed in this summary.

The document only broadly states:

"Method comparison and user studies for glucose were conducted with home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system."
"Accuracy at extreme glucose values were also evaluated." (No specific results provided)
"Clinical and analytical testing demonstrated that the GlucoSure Link Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate."

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

Test Set Sample Size: Not explicitly stated for either non-clinical or clinical testing. The document generally mentions "method comparison and user studies."
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given that the submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan, and the device is intended for "self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home," the studies would likely involve prospective collection of human blood samples in a clinical setting or by home users. However, the specific location and nature (retrospective/prospective) of the data collection are not detailed.

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

Not applicable in the context of this device and the type of evaluation described. For blood glucose monitoring systems, the "ground truth" (reference measurement) is typically established using a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods on a spectrophotometer), not human expert review. The document does not mention human experts establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication processes (like 2+1 or 3+1 expert consensus) are typically used for subjective interpretations, such as image analysis for AI models. For a quantitative device like a blood glucose meter, the ground truth is a numerical measurement from a reference instrument.

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:

Not applicable. This device is a blood glucose monitoring system, not an AI-driven image analysis or diagnostic tool that assists human readers. Therefore, an MRMC study and
measurement of human reader improvement with AI assistance are not relevant to this device.

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

The GlucoSure Link Blood Glucose Monitoring System itself performs the measurement. Its "algorithm" is the measurement methodology. The "standalone performance" is essentially the device's accuracy and precision compared to a reference method, which is generally what "method comparison" studies evaluate. The document indicates these studies were performed, showing "substantial equivalence."

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

The ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) that are highly accurate and precise. The document implies "method comparison" studies were done, which means the device's readings were compared against such a reference method.

8. The sample size for the training set:

Not explicitly stated. For a blood glucose meter, "training" might refer to the initial development and calibration of the electrochemical system and algorithms. This information is typically part of the device's internal development process and not usually detailed as a "training set" sample size in an FDA 510(k) summary in the way it is for AI models.

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

Similar to point 8, the "ground truth" for the development and calibration of the device would likely be established using laboratory reference methods to ensure the meter's internal algorithms accurately convert electrochemical signals into glucose readings.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2022

Apex Biotechnology Corp. Lisa Liu Manager of Quality Assurance Department No. 7, Li-Hsin Rd. V, Hsinchu Science Park Hsinchu. 30078 Taiwan

Re: K212140

Trade/Device Name: GlucoSure Link Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 13, 2022 Received: May 16, 2022

Dear Lisa 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. 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

{1}------------------------------------------------

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,

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212140

Device Name

GlucoSure Link Blood Glucose Monitoring System

Indications for Use (Describe)

The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips.

The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

510(k) Number:	K212140
Submitter:	Apex Biotechnology Corp.
	No. 7, Li-Hsin Road V, Hsinchu Science Park
	Hsinchu, 30078
	CHINA (TAIWAN)
Contact Person:	Lisa Liu
	Manager of Quality Assurance Division
	Apex Biotechnology Corp.
	No. 7, Li-Hsin Road V, Hsinchu Science Park
	Hsinchu, 30078
	CHINA (TAIWAN)
	email: lisaliu@apexbio.com
	Phone: 011-886-3-5641952FAX: 011-886-3-5678021
Date Prepared:	09/13/2020
Trade Names:	GlucoSure Link Blood Glucose Monitoring System
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	NBW
Predicate Devices:	AutoSure Voice II Blood Glucose System (K102037)
Device Description:	The GlucoSure Link blood glucose monitoring system consists of theGlucoSure Link meter, GlucoSure Link Blood Glucose Test Strips andContrex Plus glucose control solution. It is used for testing of bloodglucose by self-testers at home. The GlucoSure Link Blood Glucose TestStrips and Contrex Plus glucose control solution are purchased separately.
	The modified device of GlucoSure Link glucose meter is derived fromthe existing device of AutoSure Voice II meter and the modified devicecontain the Bluetooth function to transfer glucose results to the mobiledevice and removed the voice Feature.
	The glucose test strips and glucose control solution utilized in theGlucoSure Link Blood Glucose Monitoring System are the same as theAutoSure glucose test strips and Contrex Plus Glucose Control Solution,previously cleared in K102037.
	The meter materials of GlucoSure Link glucose meter are the same as the
	AutoSure Voice II meter. Therefore, the disinfection performance(robustness of meter to multiple cleanings and disinfections) was
	previously cleared in K150396.
Intended Use:	The GlucoSure Link Blood Glucose Monitoring System is comprised of
	GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose
	Test Strips.
	The GlucoSure Link Blood Glucose Monitoring System is intended for the
	quantitative measurement of glucose in fresh capillary whole bloodsamples drawn from the fingertips, forearm, or palm. Alternative site
	testing should be performed only during steady-state (when glucose is not
	changing rapidly). This system is intended for self-testing (outside the
	body, or In Vitro Diagnostic use) by people with diabetes at home as an aid
	to monitor the effectiveness of your diabetes control and should only be
	used by a single patient and not be shared. It is not intended to be used for
	the diagnosis or screening of diabetes or for use on neonates.
Comparison ofTechnologicalCharacteristics:	The GlucoSure Link Blood Glucose meter uses the same test strip and testalgorithm as the predicate. The changes was for
	• Voice Feature was removed.
	• Bluetooth connectivity was added to the meter.
	• Added error message
	Err5:Bluetooth failure,
	Err6:During bonding procedure, authorization by meter fails,
	Err7:During data transmission via BLE, a strip was inserted
	Err8:If meter is master mode and when BLE disconnection
	between meter and cell-phone happens during transmissionprocedure, meter shall show error message
	• Change in name from AutoSure Voice II Blood GlucoseMonitoring System to GlucoSure Link Blood Glucose MonitoringSystem.
	• The GlucoSure Link Blood Glucose Monitoring System sharesidentical glucose test strips with AutoSure Voice II Blood GlucoseMonitoring System, but only change in brand name fromAutoSure Blood Glucose Test Strips to GlucoSure Link BloodGlucose Test Strips.

Non-ClinicalTesting:	Testing was conducted as follows: EMC and Electrical Safety, Softwareverification and validation including cybersecurity management, linearity,precision, short sample detection, intermittent sampling, sampleperturbation, temperature and humidity testing and results demonstratesubstantial equivalence to the predicate system.
	Clinical Testing	Method comparison and user studies for glucose were conducted withhome users, including evaluation of ease of use and ease of understandingof the user manual. Results demonstrate substantial equivalence to thepredicate system. Accuracy at extreme glucose values were also evaluated.
		Conclusion:	Clinical and analytical testing demonstrated that the GlucoSure LinkBlood Glucose Monitoring System perform in a substantially equivalentmanner to that of the predicate. We conclude that the GlucoSure LinkBlood Glucose Monitoring System is substantially equivalent to thepredicate system.

{4}------------------------------------------------

{5}------------------------------------------------

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.