The BGM014 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitto diagnostic use), It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.

The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in yenous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.

Device Description

The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose. The BGM014 Pro blood glucose meter and BGM014 Pro test strips are used for professional testing of blood glucose.

AI/ML Overview

The provided text describes the BGM014 Blood Glucose Monitoring System and BGM014 Pro Blood Glucose Monitoring System. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it implicitly indicates that the device's performance must demonstrate "substantial equivalence to the predicate system" based on various tests. For blood glucose monitoring systems, this typically aligns with accuracy standards set by organizations like ISO or FDA guidance documents. The study results are reported as meeting this substantial equivalence.

Implied Acceptance Criteria (based on common standards for blood glucose meters) and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy within acceptable limits compared to reference method (e.g., laboratory analyzer)	"Results demonstrate substantial equivalence to the predicate system."
Precision within acceptable limits	Precision testing was conducted. "Results demonstrate substantial equivalence to the predicate system."
Linearity across the measuring range	Linearity testing with validation of Lo/Hi detection was conducted. "Results demonstrate substantial equivalence to the predicate system."
Performance under varying environmental conditions (temperature, humidity, altitude)	Temperature and humidity testing, altitude testing were conducted. "Results demonstrate substantial equivalence to the predicate system."
Performance with varying hematocrit levels	Hematocrit performance testing was conducted. "Results demonstrate substantial equivalence to the predicate system."
No significant interference from common substances	Interference testing was conducted. "Results demonstrate substantial equivalence to the predicate system."
Disinfection robustness	Disinfection performance (robustness of meter to multiple cleanings and disinfections) was conducted. "Results demonstrate substantial equivalence to the predicate system."
Software verification and validation	Software verification and validation was conducted. "Results demonstrate substantial equivalence to the predicate system."
Sample volume verification	Sample volume verification was conducted. "Results demonstrate substantial equivalence to the predicate system."
Qualification of control solutions	Qualification of control solutions was conducted. "Results demonstrate substantial equivalence to the predicate system."

Study Details:

Sample size used for the test set and the data provenance:
- The document states: "An accuracy study was conducted with home users and professional users using finger, palm and forearm capillary whole blood. Venous blood testing was also done by the professional users."
- However, the specific sample sizes for the test sets are not provided in the given text.
- The data provenance (e.g., country of origin, retrospective or prospective) for the clinical study is not explicitly stated. It's implied to be prospective as it's an "accuracy study conducted with home users and professional users."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. For blood glucose monitoring systems, ground truth is typically established using a highly accurate laboratory reference method, not necessarily by "experts" in the sense of radiologists.
Adjudication method for the test set:
- This information is not provided as it's not typically relevant for blood glucose meter accuracy studies where direct comparison to a reference method is used.
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:
- This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. Therefore, a MRMC comparative effectiveness study is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device functions as a standalone blood glucose meter. The "accuracy study" inherently represents the standalone performance of the device without human interpretation (beyond the user applying the blood sample and reading the displayed result).
The type of ground truth used:
- While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., a YSI analyzer) which is considered highly accurate.
The sample size for the training set:
- This is a medical device for measuring blood glucose, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

December 23, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, TAIWAN

Re: K161299

Trade/Device Name: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: November 30, 2016 Received: December 5, 2016

Dear Hsue-Mei Lee:

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kellie B. Kelm -S

for: Courtney H. Lias, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161299

Device Name BGM014 Blood Glucose Monitoring System

Indications for Use (Describe)

The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.

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) K161299

Device Name

BGM014 Pro Blood Glucose Monitoring System

Indications for Use (Describe)

The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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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9 510(k) Summary

Submitter:	Apex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)
Contact Person:	Hsue-mei LeeManager of Quality Assurance DepartmentApex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	Dec 19, 2016
Trade Names:	BGM014 Blood Glucose Monitoring SystemBGM014 Pro Blood Glucose Monitoring System
Classification:	Glucose test system, 21 CFR 862.1345, Class IISingle (specified) analyte controls (assayed and unassayed), Class I, 21CFR 862.1660
Product Codes:	NBW, LFR, JJX
Predicate Devices:	AutoSure HT Blood Glucose Monitoring System (K131750)
Device Description:	The BGM014 blood glucose meter and BGM014 test strips are used forself-testing of blood glucose. The BGM014 Pro blood glucose meter andBGM014 Pro test strips are used for professional testing of bloodglucose.
Intended Use:	BGM014 System: The BGM014 Blood Glucose Monitoring System isintended for the quantitative measurement of glucose in fresh capillary wholeblood samples drawn from the fingertips, forearm, or palm. Alternative sitetesting should be performed only during steady-state (when glucose is notchanging rapidly). Testing is done outside the body (In Vitro diagnosticuse). It is intended for self-testing by people with diabetes at home as an aidto monitor the effectiveness of diabetes control. It should only be used by asingle patient and it should not be shared. It is not indicated for the diagnosisof or screening for diabetes or for neonatal use.
	The BGM014 Blood Glucose Monitoring System is comprised of theBGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.
	The Contrex Plus 5 glucose control solution is used with the BGM014 Meterand BGM014 Test Strip, to verify that the meter and test strip are workingtogether properly and that the test is performing correctly.
Intended Use:	BGM014 Pro System: The BGM014 Pro Blood Glucose Monitoring Systemis intended for quantitatively measurement of glucose in venous wholeblood, or capillary whole blood drawn from fingertips, palm, or forearm.Alternative site testing should be performed only during steady-state (whenglucose is not changing rapidly). Testing is done outside the body (In Vitrodiagnostic use). It is intended for multiple-patient use in professionalhealthcare settings as an aid to monitor effectiveness of diabetes controlprogram. This system should only be used with single use, auto-disablinglancing devices. It is not indicated for the diagnosis of or screening fordiabetes or for neonatal use.
	The BGM014 Pro Blood Glucose Monitoring System is comprised of theBGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose TestStrip.
	The Contrex Plus 5 glucose control solution is used with the BGM014 ProMeter and BGM014 Pro Test Strip, to verify that the meter and test strip areworking together properly and that the test is performing correctly.

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510(k) Summary (Continued)

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510(k) Summary (Continued)

Non-ClinicalTesting:	Testing was conducted as follows: EMC and Electrical Safety, disinfectionperformance (robustness of meter to multiple cleanings and disinfections),software verification and validation, linearity testing with validation of Lo/Hidetection, temperature and humidity testing, sample volume verification,precision testing, interferences testing, altitude testing, qualification ofcontrol solutions, hematocrit performance testing, Results demonstratesubstantial equivalence to the predicate system.
Clinical Testing	An accuracy study was conducted with home users and professional usersusing finger, palm and forearm capillary whole blood. Venous blood testingwas also done by the professional users. Results demonstrate substantialequivalence to the predicate system.
Conclusion:	Clinical and non-clinical testing demonstrated that the BGM014 andBGM014 Pro systems perform in a substantially equivalent manner to that ofthe predicate. We conclude that the BGM014 and BGM014 Pro systems aresubstantially equivalent to the predicate system.

Non-ClinicalTesting:

Testing was conducted as follows: EMC and Electrical Safety, disinfectionperformance (robustness of meter to multiple cleanings and disinfections),software verification and validation, linearity testing with validation of Lo/Hidetection, temperature and humidity testing, sample volume verification,precision testing, interferences testing, altitude testing, qualification ofcontrol solutions, hematocrit performance testing, Results demonstratesubstantial equivalence to the predicate system.

Clinical Testing

An accuracy study was conducted with home users and professional usersusing finger, palm and forearm capillary whole blood. Venous blood testingwas also done by the professional users. Results demonstrate substantialequivalence to the predicate system.

Conclusion:

Clinical and non-clinical testing demonstrated that the BGM014 andBGM014 Pro systems perform in a substantially equivalent manner to that ofthe predicate. We conclude that the BGM014 and BGM014 Pro systems aresubstantially equivalent to the predicate system.

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.