MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

K120448 · Apex BioTechnology Corp. · CGA · Apr 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120448
• Device Name: MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device system is intended for single-patient (MEG-2B) or multiple-patient use (MEG-2B Pro).

Device Story

Blood glucose monitoring system; includes meter, test strips, and control solutions. Input: fresh capillary whole blood sample applied to test strip. Principle: electrochemical measurement of glucose. Output: quantitative glucose concentration displayed on meter. MEG-2B version for home use by patients; MEG-2B Pro version for clinical use by healthcare professionals. Pro version requires single-use, auto-disabling lancing devices. Healthcare providers use output to monitor diabetes management. Benefits: provides rapid glucose data for glycemic control.

Clinical Evidence

No clinical data. Bench testing only, including EMC, electrical safety, drop testing, test strip holder qualification, software verification/validation, control solution qualification, and linearity testing.

Technological Characteristics

Electrochemical glucose monitoring system. Components: meter, test strips, control solutions. Modified strip dimensions: 38x6x0.4 mm. Sample channel: 1.4W x 3.4L x 0.135H mm. Sample volume: ≥0.8ul. Coding: 7-code system. Altitude range: up to 10,335 feet. Disinfection: validated for use with EPA-registered bleach-based wipes.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm) for patients with Diabetes Mellitus. MEG-2B for single-patient lay use; MEG-2B Pro for multi-patient clinical use by healthcare professionals. Contraindicated for diabetes diagnosis, screening, and neonatal use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MEG-2 and MEG-2 Multi Blood Glucose Monitoring System (k101204)

Submission Summary (Full Text)

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KI2OYYS

# APR - 6 2012

# 510(k) Summary

| Submitter: | Apex Biotechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078<br>CHINA (TAIWAN) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Liu<br>Assistant Manager of Quality Assurance Department<br>Apex Biotechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078<br>CHINA (TAIWAN)<br><br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | February 6, 2012 |
| Trade Names: | MEG-2B Blood Glucose Monitoring System<br>MEG-2B Pro Blood Glucose Monitoring System<br>MEG-2B Blood Glucose Test Strips<br>MEG-2B Pro Blood Glucose Test Strips<br>MEG-2B Glucose Control Solutions |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II<br>Single (specified) analyte controls (assayed and unassayed), Class I, 21<br>CFR 862.1660, |
| Product Codes: | CGA, NBW; JJX |
| Predicate Device: | MEG-2 Blood Glucose Monitoring System (k101204)<br>MEG-2 Multi Blood Glucose Monitoring System (k101204)<br>MEG-2 Blood Glucose Test Strip (k101204)<br>MEG-2 Multi Blood Glucose Test Strip (k101204)<br>MEG-2 Glucose Control Solution (k101204) |
| Device Description: | The MEG-2B blood glucose meter and MEG-2B test strips are used for<br>testing of blood glucose by self-testers at home. The MEG-2B Pro meter<br>and strips are identical to the MEG-2B versions except they are sold with<br>labeling oriented toward the professional user, rather than the self-testing<br>home user. MEG-2B Glucose Control Solutions are used for quality<br>control 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 whole<br>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<br>Monitoring System is intended for the quantitative measurement of glucose in fresh<br>capillary whole blood samples drawn from the fingertips, forearm, or palm. It is<br>indicated to be use for multiple patients in a clinical setting by healthcare professionals,<br>as an aid to monitoring levels in Diabetes Mellitus. This system is only used with<br>single-use, auto-disabling lancing device. It is not indicated for the diagnosis or<br>screening of diabetes or for neonatal use. |
| | MEG-2B Blood Glucose Test Strips: The MEG-2B Blood Glucose Test Strips are to be<br>used with the MEG-2B Blood Glucose Meters to quantitatively measure glucose in<br>capillary whole blood taken from fingertips, palm, or forearm. They are intended for lay<br>use by people with diabetes and should only be used by a single patient. This system<br>should not be shared. They are not indicated for the diagnosis or screening of diabetes<br>or for neonatal use. |
| | MEG-2B Pro Blood Glucose Test Strips: The MEG-2B Pro Blood Glucose Test Strips<br>are to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose in<br>capillary whole blood taken from a fingertip, palm, or forearm. It is indicated in a<br>clinical setting to be used for multiple patients by healthcare professionals. This system<br>is only used with single-use, auto-disabling lancing device. |
| | MEG-2B Glucose Control Solutions: The purpose of the control solution test is to<br>validate the performance of the Blood Glucose Monitoring System using a testing<br>solution with a known range of glucose. A control test that falls within the acceptable<br>range indicates the user's technique is appropriate and the test strip and meter are<br>functioning 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 strips<br>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. |
| 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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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 [phone]. 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 [phone] or [phone] 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)

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

K120448 510(k)

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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

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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

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