GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

K142689 · Apex BioTechnology Corp. · CGA · Aug 6, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142689
• Device Name: GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GAL-1F 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 blood glucose 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-1F 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. 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 blood glucose levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Story

GAL-1F/GAL-1F Pro systems measure glucose in fresh capillary whole blood (fingertip, forearm, palm). System comprises meter and test strips. GAL-1F intended for single-patient home use; GAL-1F Pro intended for multi-patient clinical use with single-use, auto-disabling lancets. Principle of operation involves electrochemical measurement of glucose; uses same test strip and algorithm as predicate. Meter design changes include relocated test strip holder and removal of strip ejection mechanism. Software supports data download. Healthcare providers/patients use output to monitor glucose levels in Diabetes Mellitus. Alternative site testing restricted to steady-state conditions.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including disinfection efficacy studies demonstrating complete inactivation of HBV/HbsAg using specified EPA-registered wipes, and robustness studies simulating 5 years (single-patient) and 3 years (multiple-patient) of cleaning/disinfection cycles with no degradation in performance or materials.

Technological Characteristics

Electrochemical glucose monitoring system. Uses same test strip and algorithm as predicate. Features include data download capability. Meter design modified to relocate test strip holder and remove ejection mechanism. Tested for EMC, electrical safety, and disinfection robustness.

Indications for Use

Indicated for people with diabetes (lay use for GAL-1F; professional use for GAL-1F Pro) as an aid to monitor blood glucose levels. Not indicated 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-1E and GAL-1E Multi (k113547) Blood Glucose Monitoring Systems

Submission Summary (Full Text)

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

August 6, 2015

APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN RD. V, HSINCHU SCIENCE PARK HSINCHU, TAIWAN, ROC

Re: K142689

Trade/Device Name: GAL-1F Blood Glucose Monitoring System. GAL-1F Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW Dated: July 7, 2015 Received: July 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Courtney H. Lias -S

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

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| SEDIVALS MAMUH GHA HEATH AND SERVICES | Form Approved: OMB No. 0910-0120 |
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| DEPARTMENT OF HEALTH AND HUMMA SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0810-0120<br>piration Date: January 31, 2017 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
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| R142689<br>510(k) Number (if known | |
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## 510(k) Summary

| Submitter | Hsue-mei Lee<br>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] |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Hsue-mei Lee<br>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 | Aug 04, 2015 |
| Trade Names | GAL-1F Blood Glucose Monitoring System<br>GAL-1F Blood Glucose Test Strips<br>GAL-1F Pro Blood Glucose Monitoring<br>GAL-1F Pro Blood Glucose Test Strips |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Devices | GAL-1E and GAL-1E Multi (k113547) Blood Glucose Monitoring Systems |
| Device Description | The GAL-1F blood glucose monitoring system consists of the GAL-1F meter<br>and GAL-1F Test Strips. It is used for testing of blood glucose by self-testers at<br>home. The GAL-1F Pro blood glucose monitoring system consists of the<br>GAL-1F Pro meter and GAL-1F Pro Test Strips. It is used for testing of blood<br>glucose by professional testers in healthcare facilities. The GAL-1F and GAL-<br>1F Pro systems are identical other than trade names and details of product<br>labeling. |
| Intended Use | The GAL-1F Blood Glucose Monitoring System is intended for the quantitative<br>measurement of glucose in fresh capillary whole blood samples drawn from the<br>fingertips, forearm, or palm. Alternative site testing should be performed only during<br>steady-state (when glucose is not changing rapidly). Testing is done outside the body<br>(In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to<br>monitoring blood glucose levels in Diabetes Mellitus and should only be used by a<br>single patient and it should not be shared. It is not indicated for the diagnosis or<br>screening of diabetes or for neonatal use.<br><br>The GAL-1F Pro Blood Glucose Monitoring System is intended for the quantitative<br>measurement of glucose in fresh capillary whole blood samples drawn from the<br>fingertips, forearm, or palm. Alternative site testing should be performed only during<br>steady-state (when glucose is not changing rapidly). Testing is done outside the body<br>(In Vitro diagnostic use). It is indicated to be used for multiple patients in a clinical<br>setting by healthcare professionals, as an aid to monitoring blood glucose levels in<br>Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is<br>not indicated for the diagnosis or screening of diabetes or for neonatal use. |
| Comparison of<br>Technological<br>Characteristics | The GAL-1F and GAL-1F Pro meters uses the same test strip, test strip holder, and test<br>algorithm as the predicate. The test strip holder has been moved from the top of the<br>predicate meter to the bottom of the new meter and the test strip ejection mechanism of<br>the predicate has been eliminated. Software has been modified to support data<br>download functionality. |
| Non-Clinical<br>Testing | Software verification and validation, linearity and detection limit testing, EMC and<br>Electrical Safety testing, and drop testing were done. Disinfection and "robustness”<br>testing were done to qualify several recommended disinfection solutions. Results<br>demonstrate substantial equivalence to the predicate device. |
| Clinical Testing | An accuracy user study was performed with blood testing by 114 self-testers and with<br>professional testing. 106 unaltered samples were tested by self-testers. An Ease-of-Use<br>and Ease-of-Understanding (of the instructions for use) questionnaire were<br>administered. Results demonstrate substantial equivalence to the predicate. |
| Conclusion | Clinical and non-clinical testing show that the GAL-1F / GAL-1F Pro Blood Glucose<br>Monitoring System perform in a substantially equivalent manner to that of the<br>predicate device. |

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## 510(k) Summary (Continued)