MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips.

The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

Device Description

The MultiSure GK Link Blood Glucose and Ketone Monitoring System consists of the MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control solution are purchased separately.
MultiSure GK Link Blood Glucose and Ketone Monitoring System enables automatic transmission of stored data to a data management system using upload data via USB cable (optional), or mobile device with Bluetooth when the meter and data management systems are properly configured.
The glucose test strips and glucose control solution utilized in the MultiSure GK Link Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips and Contrex Plus 4 Glucose Control Solution, previously cleared in K170267; The ketone test strips and ketone control solution are the same as the KET-1 Blood Ketone test strips and KET-1 ketone control solution, previously cleared in K182593.

AI/ML Overview

Here's an analysis of the provided text, extracting information related to acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides information on the accuracy studies for both glucose and ketone measurements. The acceptance criteria for these are described in the device's previous clearances (K170267 for glucose and K182593 for ketone). While the exact numerical acceptance criteria are not explicitly stated within this specific 510(k) summary for this device (K201880), it notes that the systems used are the same as previously cleared products, implying they meet the previously established criteria. The reported performance is that the "Results demonstrate substantial equivalence to the predicate system."

Given the information available, a table would look like this:

Measurement Type	Acceptance Criteria (Implied)	Reported Device Performance
Blood Glucose	Performance criteria established in K170267	Substantially equivalent to the predicate system (K091547)
Blood Ketone	Performance criteria established in K182593	Substantially equivalent to the predicate system (K091547)
Ease of Use & Understanding (User Manual)	Not explicitly detailed for this 510(k), but assessed in clinical study	Substantially equivalent to the predicate system (K091547)

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

Sample Size for Test Set: The document does not explicitly state the numerical sample size for the "accuracy studies for glucose and ketone" or the "evaluation of ease of use." It only mentions that these studies were "conducted with home users."
Data Provenance: Not specified within this document. The submitter is from Hsinchu, Taiwan, but the location where the clinical studies were performed is not mentioned. It is prospective, as it involves human participants (home users) in a clinical study.

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

This document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For blood glucose and ketone monitoring systems, ground truth is typically established by comparative measurements against a laboratory reference method, not necessarily by expert consensus in the way a diagnostic imaging study might.

4. Adjudication Method for the Test Set:

Not applicable or specified. For glucose and ketone measurements, adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging-based assessments where human interpretation is involved. For quantitative measurements against a reference standard, direct comparison is the method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance, particularly in imaging diagnostics. This device is a quantitative blood analyzer for self-testing, so this type of study is not relevant.

6. Standalone Performance (Algorithm Only Without Human-in-the-loop Performance):

Yes, a standalone performance study was done for the device itself. The "accuracy studies for glucose and ketone" assess the performance of the device (meter and test strips) in measuring blood glucose and ketone levels. While performed by "home users," the focus is on the device's ability to provide accurate readings, not on human interpretation of those readings.

7. Type of Ground Truth Used:

For the "accuracy studies for glucose and ketone," the ground truth would typically be established by a laboratory reference method. This is standard for quantitative diagnostic devices like blood glucose and ketone meters, where the device's readings are compared against a highly accurate and precise laboratory analyzer. The document states "accuracy studies," which implies comparison to a gold standard.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. This is often not explicitly detailed for diagnostic devices that rely on established electrochemical biosensor technology, as opposed to devices employing complex machine learning or AI models that require extensive "training" data. The technology itself (Glucose Oxidase for glucose, $\beta$-hydroxybutyrate dehydrogenase for ketone) is well-understood and the "training" would have been part of the initial development and calibration of the test strips and meter, not necessarily a distinct "training set" in the context of AI/ML.

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

As with point 8, the concept of a "training set" and its associated ground truth establishment isn't directly applicable in the same way for this type of device as it would be for an AI/ML diagnostic. The ground truth for the development and calibration of the technology would have been established through rigorous laboratory testing using reference methods and known concentrations of glucose and ketone.

Summary

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October 15, 2021

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

Re: K201880

Trade/Device Name: MultiSure GK Link Blood Glucose and Ketone Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW. JIN Dated: February 9, 2021 Received: February 12, 2021

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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201880

Device Name

MultiSure GK Link Blood Glucose and Ketone Monitoring System

Indications for Use (Describe)

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

510(k) number	K201880
Submitter:	Apex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)
Contact Person:	Lisa LiuManager of Quality Assurance DivisionApex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: lisaliu@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678021
Trade Names:	MultiSure GK Link Blood Glucose and Ketone Monitoring System
Classification:	Blood glucose test system, over the counter, 21 CFR 862.1345, Class IIKetones (nonquantitative) test system, 21 CFR 862.1435, Class I, meetsthe limitation of exemption 21 CFR 862.9(c)(5).
Product Codes:	NBW • JIN
Predicate Devices:	Nova Max Plus Blood Glucose and β-Ketone Monitoring System(K091547)
Device Description:	The MultiSure GK Link Blood Glucose and Ketone Monitoring Systemconsists of the MultiSure GK Link Blood Glucose and Ketone Meter,MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone teststrips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 andLevel 3), and KET-1 ketone control solution (Level 1 and Level 2). Thesystem is for self-testing of blood glucose and blood ketone. The MultiSureGK Blood Glucose test strips, MultiSure GK Blood Ketone test strips,Contrex Plus 4 Glucose Control Solution, and KET-1 ketone controlsolution are purchased separately.MultiSure GK Link Blood Glucose and Ketone Monitoring Systemenables automatic transmission of stored data to a data managementsystem using upload data via USB cable (optional), or mobile device with
	Bluetooth when the meter and data management systems are properlyconfigured.The glucose test strips and glucose control solution utilized in the MultiSureGK Link Blood Glucose and Ketone Monitoring System are the same asthe BGM009 glucose test strips and Contrex Plus 4 Glucose ControlSolution, previously cleared in K170267; The ketone test strips and ketone
	control solution are the same as the KET-1 Blood Ketone test strips andKET-1 ketone control solution, previously cleared in K182593.
Intended Use:	MultiSure GK Link Blood Glucose and Ketone Monitoring System:MultiSure GK Link Blood Glucose and Ketone Monitoring System iscomprised of the MultiSure GK Blood Glucose and Ketone Meter, theMultiSure GK Blood Glucose Test Strips, and the MultiSure GK BloodKetone test strips.
	The MultiSure GK Link Blood Glucose and Ketone Monitoring System isintended to quantitatively measure blood glucose or blood ketone in freshcapillary whole blood drawn from fingertips. The system is intended forself-testing outside the body (in vitro diagnostic use) by people withdiabetes mellitus at home as an aid in monitoring the effectiveness ofdiabetes control and should only be used by a single patient and it shouldnot be shared. It is not intended for diagnosis or screening of diabetes orfor neonatal use.
Comparison ofTechnologicalCharacteristics:	Glucose measurement is based on electrochemical biosensor technologyusing the enzyme Glucose Oxidase (GOD) The MultiSure GK BloodGlucose test strips contains the enzyme, GOD, when blood flow into thereaction zone, the enzyme reacts with glucose in blood and produceselectrical current. The MultiSure GK Link Blood Glucose and Ketonemeter measures the current and shows the test result in 5 seconds. Thetechnological characteristics of MultiSure GK Link Blood Glucose andKetone Monitoring System are substantially equivalent to the predicatesystem (K091547).
	Ketone measurement is based on electrochemical biosensor technologyusing the enzyme $\beta$ -hydroxybutyrate dehydrogenase (HBDH). TheMultiSure GK Blood Ketone test strips contains the enzyme, HBDH, whenblood flow into the reaction zone, the enzyme reacts with $\beta$ - Hydroxybutyrate ( $\beta$ -ketone) in blood and produces electrical current. TheMultiSure GK Link Blood Glucose and Ketone meter measures the current
	and shows the test result in 8 seconds. The technological characteristics ofMultiSure GK Link Blood Glucose and Ketone Monitoring System aresubstantially equivalent to the predicate system (K091547).
Non-ClinicalTesting:	Testing was conducted as follows: EMC and Electrical Safety, disinfection
	performance (robustness of meter to multiple cleanings and disinfections),software verification and validation including cybersecurity management,precision testing, repeatability testing, temperature and humidity testing,intermittent sampling testing, sample perturbation testing, stability andresults demonstrate substantial equivalence to the predicate system.
Clinical Testing	Accuracy studies for glucose and ketone were conducted with home users,including evaluation of ease of use and ease of understanding of the usermanual. Results demonstrate substantial equivalence to the predicatesystem.
Conclusion:	Clinical and analytical testing demonstrated that the MultiSure GK LinkBlood Glucose and Ketone Monitoring System perform in a substantiallyequivalent manner to that of the predicate. We conclude that the MultiSureGK Link Blood Glucose and Ketone Monitoring System is substantiallyequivalent to the predicate system.

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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.