MEG-2B Blood Glucose Monitoring System: The MEG-2B 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. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. This system 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 is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is indicated to be use for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

MEG-2B Blood Glucose Test Strips: The MEG-2B Blood Glucose Test Strips are to be used with the MEG-2B Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

MEG-2B Pro Blood Glucose Test Strips: The MEG-2B Pro Blood Glucose Test Strips are to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing device.

MEG-2B Glucose Control Solutions: The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Device Description

The MEG-2B blood glucose meter and MEG-2B test strips are used for testing of blood glucose by self-testers at home. The MEG-2B Pro meter and strips are identical to the MEG-2B versions except they are sold with labeling oriented toward the professional user, rather than the self-testing home user. MEG-2B Glucose Control Solutions are used for quality control testing of the system.

AI/ML Overview

The provided 510(k) summary for the MEG-2B Blood Glucose Monitoring System indicates that no clinical testing was performed. Therefore, there are no specific acceptance criteria or a study proving the device meets those criteria through clinical performance outlined in this document.

The submission focuses entirely on non-clinical testing to demonstrate substantial equivalence to the predicate device.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical testing was performed, there are no acceptance criteria for clinical performance explicitly stated in this document. The non-clinical testing focused on demonstrating substantial equivalence to the predicate device.

Acceptance Criteria Category (Non-Clinical)	Reported Device Performance
EMC and Electrical Safety	Results demonstrate substantial equivalence to the predicate system.
Drop Testing	Results demonstrate substantial equivalence to the predicate system.
Test Strip Holder Qualification	Results demonstrate substantial equivalence to the predicate system.
Software Verification and Validation (incl. unit integration testing)	Results demonstrate substantial equivalence to the predicate system.
Control Solution Qualification	Results demonstrate substantial equivalence to the predicate system.
Linearity Testing with Validation of Lo/Hi detection	Results demonstrate substantial equivalence to the predicate system.

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

Sample Size for Test Set: Not applicable, as no clinical test set was used.
Data Provenance: Not applicable, as no clinical data was used. The non-clinical tests were conducted by the manufacturer.

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

Not applicable, as no clinical test set was used, and thus no expert ground truth was established for clinical performance.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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-assisted diagnostic imaging device that would typically involve human readers. No MRMC study was performed.

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

This refers to the intrinsic analytical performance of the device (meter and test strip) in measuring glucose concentrations. The "Non-Clinical Testing" section mentions "linearity testing," which assesses the device's accuracy across a range of glucose concentrations, a form of standalone performance evaluation. The results concluded substantial equivalence to the predicate system.

7. The type of ground truth used

For the non-clinical tests (e.g., linearity), the ground truth would typically be established using a reference laboratory method for glucose measurement (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. This is implied by "linearity testing with validation of Lo/Hi detection."

8. The sample size for the training set

Not applicable. The description does not indicate the use of machine learning or AI models that would require a training set. The device appears to utilize a fixed algorithm, potentially derived from prior R&D, but not a "training set" in the context of recent AI development.

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

Not applicable, as no training set was identified.

Summary

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KI2OYYS

APR - 6 2012

510(k) Summary

Submitter:	Apex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)
Contact Person:	Lisa LiuAssistant Manager of Quality Assurance DepartmentApex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: lisaliu@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	February 6, 2012
Trade Names:	MEG-2B Blood Glucose Monitoring SystemMEG-2B Pro Blood Glucose Monitoring SystemMEG-2B Blood Glucose Test StripsMEG-2B Pro Blood Glucose Test StripsMEG-2B Glucose Control Solutions
Classification:	Glucose test system, 21 CFR 862.1345, Class IISingle (specified) analyte controls (assayed and unassayed), Class I, 21CFR 862.1660,
Product Codes:	CGA, NBW; JJX
Predicate Device:	MEG-2 Blood Glucose Monitoring System (K101204)MEG-2 Multi Blood Glucose Monitoring System (K101204)MEG-2 Blood Glucose Test Strip (K101204)MEG-2 Multi Blood Glucose Test Strip (K101204)MEG-2 Glucose Control Solution (K101204)
Device Description:	The MEG-2B blood glucose meter and MEG-2B test strips are used fortesting of blood glucose by self-testers at home. The MEG-2B Pro meterand strips are identical to the MEG-2B versions except they are sold withlabeling oriented toward the professional user, rather than the self-testinghome user. MEG-2B Glucose Control Solutions are used for qualitycontrol testing of the system.
Intended Use:	MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose Monitoring
	System is intended for the quantitative measurement of glucose in fresh capillary wholeblood samples drawn from the fingertips, forearm, or palm. It is indicated for lay use by
	people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only
	be used by a single patient. This system 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 GlucoseMonitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips, forearm, or palm. It isindicated to be use for multiple patients in a clinical setting by healthcare professionals,as an aid to monitoring levels in Diabetes Mellitus. This system is only used withsingle-use, auto-disabling lancing device. It is not indicated for the diagnosis orscreening of diabetes or for neonatal use.
	MEG-2B Blood Glucose Test Strips: The MEG-2B Blood Glucose Test Strips are to beused with the MEG-2B Blood Glucose Meters to quantitatively measure glucose incapillary whole blood taken from fingertips, palm, or forearm. They are intended for layuse by people with diabetes and should only be used by a single patient. This systemshould not be shared. They are not indicated for the diagnosis or screening of diabetesor for neonatal use.
	MEG-2B Pro Blood Glucose Test Strips: The MEG-2B Pro Blood Glucose Test Stripsare to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose incapillary whole blood taken from a fingertip, palm, or forearm. It is indicated in aclinical setting to be used for multiple patients by healthcare professionals. This systemis only used with single-use, auto-disabling lancing device.
	MEG-2B Glucose Control Solutions: The purpose of the control solution test is tovalidate the performance of the Blood Glucose Monitoring System using a testingsolution with a known range of glucose. A control test that falls within the acceptablerange indicates the user's technique is appropriate and the test strip and meter arefunctioning properly.
Comparison of	The MEG-2B system has been modified relative to the predicate by using a new test
Technological	strip holder in the meter and a corresponding modified test strip. The MEG-2B
Characteristics:	meter uses the same test algorithm as the predicate meter. The MEG-2B control
	solutions use the same component chemicals as the predicate, with slightly modified
	glucose levels across the three control solutions. The MEG-2B Pro meter and stripsare identical to the MEG-2B versions, except they are sold with labeling oriented
	toward the professional user, rather than the self-testing home user.
Non-Clinical	Testing was conducted as follows: EMC and Electrical Safety, drop testing, test
Testing:	strip holder qualification, software verification and validation (including unit
	integration testing), control solution qualification, and linearity testing with
	validation of Lo/Hi detection. Results demonstrate substantial equivalence to the
	predicate system.
Clinical Testing	Not applicable.
Conclusion:	Non-clinical testing demonstrated that the MEG-2B and MEG-2B Pro systems
	perform in a substantially equivalent manner to that of the predicate. We conclude
	that the two new systems are substantially equivalent to the predicate devices.

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510(k) Summary (Continued)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Apex Biotechnology Corp. c.o Lisa Liu No. 7. Li-Hsin Road V. Hsinchu Science Park Hsinchu, 30078, Taiwan

APR - 6 2012

Re: K120448

Trade Name: MEG-2B Blood Glucose Monitoring System; MEG-2B Pro Blood Glucose Monitoring System; MEG-2B Glucose Control Solutions Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: March 16, 2012 Received: March 20, 2012

Dear Ms. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you assnow of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Darrollians regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

KIZOUYO 510(k) Number (if known):

Device Name: MEG-2B Blood Glucose Monitoring System Indications for Use:

The MEG-2B 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. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The MEG-2B Blood Glucose Test Strips are to be used with the MEG-2B Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

. - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K120448 510(k)

Page 1 of 3

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Indications for Use Statement

510(k) Number (if known):

Device Name: MEG-2B Pro Blood Glucose Monitoring System Indications for Use:

The MEG-2B Pro 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. It is indicated to be use for multiple patients in a clinical w setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

120440

The MEG-2B Pro Blood Glucose Test Strips are to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is indicated in a clinical setting to be used for multiple This system is only used with single-use, patients by healthcare professionals. auto-disabling lancing device.

Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ruth Clum

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) == 12 == 4 4

Page 2 of 3

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Indications for Use Statement

K 120440 510(k) Number (if known): Device Name: MEG-2B Glucose Control Solutions Indications for Use:

The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Over-The-Counter Use _ Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Auto Club

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 120448

Page 3 of 3

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.