The BGM039 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). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes 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 indicated for the diagnosis or screening of diabetes or for neonatal use.

The BGM039 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). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes 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 indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Description

BGM039 brand of Blood Glucose Monitoring System is designed to have two variation models, BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring System is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose Monitoring System is implemented with all of the changes stated in the submission. The two meters use the same BGM039 Test Strip and Contrex Plus 4 Control Solution. This Premarket Notification (510(k)) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device, GlucoSure HT Plus Blood Glucose Monitoring System, K202885.

BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System consists of the blood glucose meter and single use test strips. It is used for testing of blood glucose by self-testers at home.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive summary. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical testing section and the overall context of a blood glucose monitoring system, we can infer some general acceptance criteria for such devices, especially concerning accuracy. The FDA's guidance for blood glucose monitoring systems generally requires specific accuracy levels.

Here's an attempt to answer your questions based on the available information and common practices for blood glucose monitoring systems, with explicit mention of where information is not provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., in terms of percentage agreement or mean absolute relative difference) nor does it provide a table of performance statistics for the accuracy test.

It mentions "accuracy test" in the non-clinical testing section, implying that such a test was conducted. For blood glucose meters, common acceptance criteria from standards like ISO 15197 (which is often referenced by the FDA) are:

Performance Metric	Acceptance Criteria (Typical ISO 15197)	Reported Device Performance (Not explicitly stated in document)
Accuracy (Glucose concentration < 100 mg/dL):	≥ 95% of results within ±15 mg/dL of lab reference	"Testing showed that the BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate." (Specific numbers not provided)
Accuracy (Glucose concentration ≥ 100 mg/dL):	≥ 95% of results within ±15% of lab reference	(Specific numbers not provided)
Intermediate Precision	Not explicitly stated in document, but performed	(Specific numbers not provided)
Within-run Precision	Not explicitly stated in document, but performed	(Specific numbers not provided)
Linearity	Not explicitly stated in document, but performed	(Specific numbers not provided)

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

Sample Size for Test Set: Not provided. The document states "no clinical testing was conducted." While it mentions "accuracy test" as part of non-clinical testing, the sample size (number of subjects or samples tested) for this test is not specified.
Data Provenance: Not explicitly stated. Given "no clinical testing was conducted," any "accuracy test" would likely be laboratory-based rather than from patients. If human samples were used in a lab setting, their origin (country, retrospective/prospective) is not mentioned.

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

This information is not provided. Since no clinical testing was conducted, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists, pathologists) does not directly apply here. For blood glucose meters, ground truth is typically established by a laboratory reference method (e.g., a YSI analyzer), not human expert consensus.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 are relevant for studies where multiple human readers interpret data, and discrepancies need to be resolved. This is not applicable to the non-clinical testing described for a blood glucose meter where ground truth is established by 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

There was no MRMC comparative effectiveness study and no mention of AI in this 510(k) submission. This type of study is not relevant for a blood glucose monitoring system, which is a diagnostic device for measuring glucose levels, not an AI-powered diagnostic imaging tool.

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

This information is not directly applicable in the context of an "algorithm only" performance as described for AI. The device itself (meter + strip) is the "algorithm" that provides the glucose measurement. The non-clinical "accuracy test" would inherently be a standalone performance evaluation of the device in a controlled setting against a reference method. The document states "no clinical testing was conducted," which implies performance was assessed without human operators collecting samples in a clinical trial setting.

7. The Type of Ground Truth Used

The most likely ground truth for an accuracy test of a blood glucose monitor is a laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated, this is standard practice for evaluating blood glucose meters. The document mentions "accuracy test" which implies comparison to a gold standard.

8. The Sample Size for the Training Set

This information is not provided. Blood glucose meters typically do not use "training sets" in the machine learning sense for their core measurement algorithm. Their performance characteristics are determined during design and manufacturing through calibration and testing. If any internal component underwent machine learning (which is unlikely but not impossible for signal processing), that information is not disclosed.

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

This information is not provided. As mentioned above, the concept of a "training set" with established ground truth as it applies to AI/ML is generally not relevant for determining the performance of a blood glucose meter.

Summary

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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

November 4, 2022

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

Re: K220421

Trade/Device Name: BGM039 Blood Glucose Monitoring System BGM039 Link Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 20, 2022 Received: July 20, 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

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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/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,

Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2022.11.04
10:26:19 -04'00'

Paula V. 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K220421

Device Name

BGM039 Blood Glucose Monitoring System

Indications for Use (Describe)

The BGM039 Blood Glucose Monitoring System is comprised of the BGM039 Blood Glucose Meter and the BGM039 Blood Glucose Test 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)

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."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220421

Device Name

BGM039 Link Blood Glucose Monitoring System

Indications for Use (Describe)

The BGM039 Link Blood Glucose Monitoring System is comprised of the BGM039 Link Blood Glucose Meter and the BGM039 Blood Glucose Test 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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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!

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."

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510(k) Summary

510(k) number	K220421
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: 011-886-3-5641952
	FAX: 011-886-3-5678021
Date Prepared	Feb 08, 2022
Trade Names	BGM039 Blood Glucose Monitoring System
	BGM039 Link Blood Glucose Monitoring System
Classification	Glucose test system, 21 CFR 862.1345, Class II
Product Codes	NBW
Predicate Devices	GlucoSure HT Plus Blood Glucose Monitoring System (K202885)
Device	BGM039 brand of Blood Glucose Monitoring System is designed to have two
Description	variation models, BGM039 Blood Glucose Monitoring System and BGM039
	Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring
	System is the models with all the changes implemented with exception to the
	addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose
	Monitoring System is implemented with all of the changes stated in the
	submission. The two meters use the same BGM039 Test Strip and Contrex Plus
	4 Control Solution. This Premarket Notification (510(k)) is intended to
	demonstrate that the candidate devices to be marketed is safe and effective as the
	predicate device, GlucoSure HT Plus Blood Glucose Monitoring System,
	K202885.
	BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose
	Monitoring System consists of the blood glucose meter and single use test strips.
	It is used for testing of blood glucose by self-testers at home.
Intended Use	BGM039 Blood Glucose Monitoring SystemThe BGM039 Blood Glucose Monitoring System is comprised of the BGM039 Blood Glucose Meter and the BGM039 Blood Glucose Test Strips.The BGM039 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). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes 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 indicated for the diagnosis or screening of diabetes or for neonatal use.BGM039 Link Blood Glucose Monitoring SystemThe BGM039 Link Blood Glucose Monitoring System is comprised of the BGM039 Link Blood Glucose Meter and the BGM039 Blood Glucose Test Strips.The BGM039 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). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes 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 indicated for the diagnosis or screening of diabetes or for neonatal use.
Comparison ofTechnologicalCharacteristics	The BGM039 Blood Glucose meter and BGM039 Link Blood Glucose meter uses the same test strip and test algorithm as the predicate. The changes was for LCD patter modification Case change: Dimensions of the meter were changed from 96Lx58Wx16H (mm) to 86Lx58Wx18H (mm). Remove Strip ejection button and USB port. Button positioning was changed from the front to the sides of the meter. Case color change BGM039 Blood Glucose meter: The color of upper case and button were changed from blue to black ; the color of lower case and battery cover were changed from white to black.
BGM039 Link Blood Glucose meter: The color of upper case was changed from blue to silver ; the color of lower case and battery cover were changed from white to silver ; the color of button was changed from blue to black.
PCB circuit change MCU change. Addition of a Bluetooth module to the BGM039 Link Blood Glucose Monitoring System for the wireless transfer of data to mobile devices. Remove USB connector, relocation of button from up to meter side and relocation of strip holder from up to the bottom of the meter.
Software change: Add Bluetooth function/display on LCD and remove the USB transmission flow. Added error massage for BGM039 Link Blood Glucose Monitoring System. Err5: Meter fails in Bluetooth status check, Err6: Bluetooth pairing is fail, Err7: Data transmission via Bluetooth is interrupted, Err8: Bluetooth disconnection between meter and mobile device occurred during transmission procedure.
Trade name of the system changed from GlucoSure HT Plus Blood Glucose Monitoring System to BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System. Meter name change from GlucoSure HT Plus meter to BGM039 meter and BGM039 Link meter. Strip name change from GlucoSure HT blood glucose strip to BGM039 blood glucose strip.
The BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System shares identical glucose test strips with GlucoSure HT Plus Blood Glucose Monitoring System, but only change in brand name from GlucoSure HT Blood Glucose Test Strips to BGM039 Blood Glucose Test Strips.
Non-ClinicalTesting	Testing was conducted as follows: Robustness test, drop test, battery life test,linearity test, intermediate precision, within-run precision, accuracy test,usability study, EMC and Electrical Safety and Software verification andvalidation including cybersecurity management, and results demonstratesubstantial equivalence to the predicate system.
Clinical Testing	No clinical testing was conducted.
Conclusion	Testing showed that the BGM039 Blood Glucose Monitoring System andBGM039 Link Blood Glucose Monitoring System perform in a substantiallyequivalent manner to that of the predicate. We conclude that the candidatedevices are substantially equivalent to the predicate device.

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510(k) Summary (Continued)

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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.