GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL

K113547 · Apex BioTechnology Corp. · CGA · Mar 28, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113547
• Device Name: GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GAL-1E 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. The GAL-1E Blood Glucose Test Strips are to be used with the GAL-1E 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. The GAL-1E Multi 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 to be used 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. The GAL-1E Multi Blood Glucose Test Strips are to be used with the GAL-1E Multi 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. They are 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 devices.

Device Story

Blood glucose monitoring system; measures glucose in capillary whole blood via test strips. Two versions: GAL-1E for single-patient home use; GAL-1E Multi for multi-patient clinical use. Input: capillary blood sample on test strip. Operation: electrochemical measurement of glucose levels. Output: quantitative glucose reading on LCD. Used by patients (home) or healthcare professionals (clinical). Clinical version requires single-use, auto-disabling lancing devices. Healthcare providers use results to monitor diabetes management. Benefits: provides rapid, quantitative glucose data for glycemic control.

Clinical Evidence

Clinical accuracy study conducted for professional use. User study data evaluated. Results demonstrate substantial equivalence to the predicate system.

Technological Characteristics

Electrochemical glucose monitoring system. Features vertical LCD, strip ejection button, and modified case. Uses same test algorithm as predicate. Test strips identical to predicate. Software verification and validation performed. Disinfection robustness validated using Hepatitis B model with Dispatch wipes.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm) for diabetes monitoring. Not for diagnosis, screening, or neonatal use. GAL-1E for single-patient lay use; GAL-1E Multi for multi-patient clinical use by healthcare professionals.

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)

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K113547

MAR 2 8 2012

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| 510(k) Summary | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Apex Biotechnology Corp. |
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| Contact Person: | Lisa Liu |
| | Assistant 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], ext 567 |
| | Fax: [phone] |
| Date Prepared: | March 22, 2012 |
| Trade Names: | GAL-1E Blood Glucose Monitoring System |
| | GAL-1E Blood Glucose Test Strips |
| | GAL-1E Multi Blood Glucose Monitoring System |
| | GAL-1E Multi 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-1E blood glucose meter and GAL-1E test strips are used for<br>testing of blood glucose. There is one version for self-testers at home<br>and a second version ("GAL-1E Multi") for professional use. Contrex |
| | Plus III Glucose Control Solutions are used for quality control testing of<br>the systems. |
| Intended Use: | |
| | GAL-1E Blood Glucose Monitoring System |
| | The GAL-1E 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-1E Blood Glucose Test Strips |
| | The GAL-1E Blood Glucose Test Strips are to be used with the GAL- |
| | 1E 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. |
| | GAL-1E Multi Blood Glucose Monitoring System |
| | The GAL-1E Multi 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 to be used 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. |
| | GAL-1E Multi Blood Glucose Test Strips |
| | The GAL-1E Multi Blood Glucose Test Strips are to be used with the |
| | GAL-1E Multi 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. They are |
| | 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 devices. |

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## 510(k) Summary (Continued)

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## 510(k) Summary (Continued)

| Comparison of<br>Technological<br>Characteristics: | The GAL-1E and GAL-1E Multi meters have been modified relative to<br>the predicate by orienting the Liquid Crystal Display (LCD) vertically<br>and rearranging its icons, adding a strip ejection button, plus altering the<br>meter case to accommodate the LCD change. The GAL-1E and GAL-<br>IE Multi meters use the same test algorithm as the predicate meter. The<br>GAL-IE and GAL-IE Multi test strips are identical to their predicate<br>devices. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical<br>Testing: | Testing was conducted as follows: EMC and Electrical Safety, drop<br>testing, disinfection performance (robustness of meter to multiple<br>cleanings and disinfections), software verification and validation, and<br>linearity testing with validation of Lo/Hi detection. Disinfection testing<br>with Dispatch wipes was done using a Hepatitis B test model. Results<br>demonstrate substantial equivalence to the predicate system. |
| Clinical Testing | An accuracy study was conducted with professional testing. User study<br>data were discussed. Results demonstrate substantial equivalence to the<br>predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the GAL-IE, and<br>GAL-1E Multi, systems perform in a substantially equivalent manner to<br>that of the predicate. We conclude that the GAL-1E and GAL-1E Multi<br>systems are substantially equivalent to the predicate system. |

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Image /page/3/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle with three lines representing its head and wings. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

10903 New Hampshire Avenue Silver Spring, MD 20993

# MAR 2 8 2012

Apex Biotechnology Corp. c/o Dr. Bruce A. MacFarlane Senior Principal Scientist 4050 Olson Memorial Hwy, Suite 450 Minneapolis, MN, 55422 USA

Re: k113547 GAL-1E Blood Glucose Monitoring System and GAL-1E Multi Blood Trade/Device Name: Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CGA, NBW Dated: March 22, 2012 Received: March 23, 2012

Dear Dr. MacFarlane,

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 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); 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 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/Resourcesfor You/Industry/default.htm

Sincerely yours,

signature

Counney 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

510(k) Number (if known): k113547

Device Name: GAL-1E Blood Glucose Monitoring System

Indications for Use:

The GAL-IE 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.

The GAL-IE Blood Glucose Test Strips are to be used with the GAL-1E 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 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

510(k) k113(4)

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### Indications for Use Statement

510(k) Number (if known): k113547

Device Name: GAL-1E Multi Blood Glucose Monitoring System

Indications for Use:

The GAL-1E Multi 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 to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellius. 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.

The GAL-IE Multi Blood Glucose Test Strips are to be used with the GAL-IE Multi 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. They are 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 devices.

Prescription Use Over-The-Counter Use X × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (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

510(k) k 113547

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