GAL-1A BLOOD GLUCOSE MONITORING SYSTEM

K113208 · Apex BioTechnology Corp. · CGA · Jan 26, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113208
• Device Name: GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

GAL-1A Blood Glucose Monitoring System: The GAL-1A 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). Testing is done outside the body (In Vitro diagnostic use). 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 and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. GAL-1A Blood Glucose Test Strips: The GAL-1A Blood Glucose Test Strips are to be used with the GAL-1A Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Story

GAL-1A Blood Glucose Monitoring System; modified version of GAL-1C (k102816). Modifications include change in meter shape/size (horizontal to vertical layout; 56Lx63Wx13H mm to 76Lx45Wx13H mm); rearrangement of display icons. Device intended for single-patient blood glucose monitoring. System validated for disinfection efficacy against hepatitis B virus (HBV) using Dispatch Hospital Cleaner Disinfectant Towels with Bleach. Robustness testing simulated 5 years of use (1825 cleaning/disinfection cycles) with no performance degradation.

Clinical Evidence

No clinical diagnostic data provided. A user study was conducted to evaluate system ease-of-use and user manual comprehension. Results demonstrated substantial equivalence to the predicate system.

Technological Characteristics

Glucose test system using electrochemical sensing. Features vertical LCD display and modified meter housing. Software verification and validation performed. Connectivity/materials not specified beyond standard meter components.

Indications for Use

Indicated for lay use by people with diabetes to monitor blood glucose levels in Diabetes Mellitus. Samples: fresh capillary whole blood from fingertips, forearm, or palm. Not for diagnosis/screening of diabetes or 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

• GAL-1C Blood Glucose Monitoring System (k102816)

Submission Summary (Full Text)

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

K113208

# JAN 2 6, 2012

. . . .

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

.

| Submitter: | Apex Biotechnology Corp. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| Contact Person: | Hsue-mei Lee |
| | Manager of Quality Assurance Department |
| | Apex Biotechnology Corp. |
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| | email: [e-mail] |
| | Phone: [phone] |
| | FAX: [phone] |
| Date Prepared: | December 27, 2011 |
| Trade Names: | GAL-1A Blood Glucose Monitoring System |
| | GAL-1A Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Device: | GAL-1C Blood Glucose Monitoring System (k102816) |
| | GAL-1C Blood Glucose Test Strip (k102816) |
| Device Description: | The GAL-1A blood glucose meter and GAL-1A test strips are used for<br>testing of blood glucose by self-testers at home. Contrex Plus III |
| | Glucose Control Solutions are used for quality control testing of the |
| | system. |
| Intended Use: | GAL-1A Blood Glucose Monitoring System: The GAL-1A 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.<br>Alternative site testing should be performed only during steady-state (when glucose<br>is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use).<br>It is indicated for lay use by people with diabetes, as an aid to monitoring levels in<br>Diabetes Mellitus and should only be used by a single patient and it should not be<br>shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal<br>use. |
| | GAL-1A Blood Glucose Test Strips: The GAL-1A Blood Glucose Test Strips are to<br>be used with the GAL-1A Blood Glucose Meter to quantitatively measure glucose<br>in capillary whole blood taken from fingertips, palm, or forearm. Alternative site<br>testing should be performed only during steady-state (when glucose is not changing<br>rapidly). They are not indicated for the diagnosis or screening of diabetes or for<br>neonatal use. |
| Comparison of<br>Technological<br>Characteristics: | The GAL-1A meter has been modified relative to the predicate by orienting<br>the Liquid Crystal Display (LCD) vertically and rearranging its icons, plus<br>altering the meter case to accommodate the LCD change. The GAL-1A<br>meter uses the same test algorithm as the predicate meter. The GAL-1A test<br>strips are identical to their predicate devices. |
| Non-Clinical<br>Testing: | Testing was conducted as follows: EMC and Electrical Safety, drop testing<br>disinfection performance (robustness of meter to multiple cleanings and<br>disinfections), software verification and validation, and linearity testing with<br>validation of Lo/Hi detection. Results demonstrate substantial equivalence to<br>the predicate system. |
| Clinical Testing | A user study was conducted to evaluate ease-of-use of the system and ease-<br>of-understanding of the User's Manual. Results demonstrate substantial<br>equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the GAL-1A system<br>performs in a substantially equivalent manner to that of the predicate. We<br>conclude that the GAL-1A meter and GAL-1A test strips are substantially<br>equivalent to the predicate devices. |

:

:

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

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

510(k) Summary (Continued)

: 上

:

:

11. 11. 11.

:

:

- - - - -

. . . . .

. .

. .

:

. ............................................................................................................................................................................

. 19

.

:

:

:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

.

.

:

:

:

:

:

:

:

. . . . . . .

.

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

# 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 graphic of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

10903 New Hampshire Avenue Silver Spring, MD 20993

Apex Biotechnology Corp. c/o Hsue-mei Lee No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, 30078 CHINA (TAIWAN)

JAN 2 6 2012

k113208 Re:

Trade Name: GAL-1A Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: December 27, 2011 Received: December 28, 2011

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.

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 (1 wr 1), it may be cosynd in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 and misms (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).

{3}------------------------------------------------

### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office 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 [phone]. For questions 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 Division 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,

AV

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

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

## Indications for Use Statement

510(k) Number (if known): k 113208

Device Name: GAL-1A Blood Glucose Monitoring System

Indications for Use:

GAL-1A Blood Glucose Monitoring System:

The GAL-1A 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). Testing is done outside the body (In Vitro diagnostic use). 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 and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

GAL-1A Blood Glucose Test Strips:

The GAL-1A Blood Glucose Test Strips are to be used with the GAL-1A Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Over-The-Counter Use X 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)

Signature

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

1113208 510(k)

Page 1 of 1