MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Description

The MEG-2B Blood Glucose Monitoring System consists of the MEG-2B meter and MEG-2B Test Strips. It is used for testing of blood glucose by self-testers at home. The MEG-2B Pro Blood Glucose Monitoring System consists of the MEG-2B Pro meter and MEG-2B Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The MEG-2B and MEG-2B Pro systems are identical other than trade names and details of product labeling.

AI/ML Overview

This document is a 510(k) premarket notification for a blood glucose monitoring system, and as such, it does not contain the detailed information about acceptance criteria and a study design that you would typically find for an AI/ML-based medical device. The device in question is a physical blood glucose meter, and the changes discussed are related to manufacturing and disinfectants, not a software algorithm or AI.

Therefore, I cannot extract the information requested for the following reasons:

No Acceptance Criteria for AI/ML performance: The document describes a blood glucose monitoring system, not an AI/ML device. Acceptance criteria discussed would relate to accuracy of glucose measurements, not AI performance metrics like sensitivity, specificity, or AUC.
No "Study" as defined for AI/ML: The "studies" mentioned are "Disinfection (viral inactivation) and 'robustness' testing," which are physical/chemical engineering tests, not clinical studies for AI/ML performance. It explicitly states, "No clinical testing was conducted."
No data on training/test sets, ground truth, experts, or MRMC studies: These concepts are entirely irrelevant to the type of device and the submission described.

The prompt specifically asks for details related to an AI/ML device's validation. This document is about a different class of medical device (in vitro diagnostic glucose meter) and its physical modifications.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

APEX BIO TECHNOLOGY CORP HSUE-MEI LEE, MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7. LI-HSIN ROAD V May 7, 2015 HSINCHU SCIENCE PARK HSINCHU 30078, TAIWAN

Re: K143750

Trade/Device Name: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: April 2, 2015 Received: April 8, 2015

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.

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

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,

Katherine Serrano -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

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

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) K143750

Device Name

MEG-2B Blood Glucose Monitoring System

Indications for Use (Describe)

The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantiative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

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}------------------------------------------------

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) K143750

Device Name

MEG-2B Pro Blood Glucose Monitoring System

Indications for Use (Describe)

The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for serecting of diabetes or for neonatal use.

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.

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."

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

510(k) Summary

Submitter	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
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	March 31, 2015
Trade Names	MEG-2B Blood Glucose Monitoring SystemMEG-2B Pro Blood Glucose Monitoring System
Classification	Glucose test system, 21 CFR 862.1345, Class II
Product Codes	CGA, NBW
Predicate Devices	MEG-2B Blood Glucose Monitoring System (K120448)MEG-2B Pro Blood Glucose Monitoring System (K120448)
Device Description	The MEG-2B Blood Glucose Monitoring System consists of the MEG-2B meterand MEG-2B Test Strips. It is used for testing of blood glucose by self-testersat home. The MEG-2B Pro Blood Glucose Monitoring System consists of theMEG-2B Pro meter and MEG-2B Pro Test Strips. It is used for testing of bloodglucose by professional testers in healthcare facilities. The MEG-2B and MEG-2B Pro systems are identical other than trade names and details of productlabeling.

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

510(k) Summary (Continued)

Intended Use	MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose MonitoringSystem, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, isintended for the quantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertips, forearm, or palm. Alternate site testing should be done only duringsteady -state times (when glucose is not changing rapidly). It is indicated for use by lay peoplewith diabetes at home as an aid to monitor the effectiveness of diabetes control. This system isintended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It isnot indicated for the diagnosis or screening of diabetes or for neonatal use.MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood GlucoseMonitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro BloodGlucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillarywhole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing shouldbe done only during steady -state times (when glucose is not changing rapidly). This system isindicated for multiple-patient use in professional healthcare settings as an aid to monitor theeffectiveness of diabetes control programs. It is only used with single-use, auto-disablinglancing device. It is intended for testing outside the body (in vitro diagnostic use). It is notindicated for the diagnosis or screening of diabetes or for neonatal use.
Comparison ofTechnologicalCharacteristics	The modified MEG-2B and MEG 2B Pro Blood Glucose Monitoring Systems areidentical to the predicate other than a) addition of silver paint to the meter case, b)change in manufacturing site for the LCD cover, and c) the recommendation of threeadditional disinfectants in the User Manuals.
Non-ClinicalTesting	Disinfection (viral inactivation) and "robustness" testing were done to qualify allrecommended disinfection solutions. Results demonstrate substantial equivalence tothe predicate.
Clinical Testing	No clinical testing was conducted.
Conclusion	Testing showed that the modified MEG-2B and MEG 2B Pro Blood GlucoseMonitoring Systems are substantially equivalent to the predicate.

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.