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 Description

The GAL-1A blood glucose meter and GAL-1A test strips are used for testing of blood glucose by self-testers at home. Contrex Plus III Glucose Control Solutions are used for quality control testing of the system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the GAL-1A Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the device being "substantially equivalent" to a predicate device (GAL-1C Blood Glucose Monitoring System K102816). Specific numerical acceptance criteria for blood glucose accuracy are not explicitly stated in the provided documents but are inferred through the declaration of substantial equivalence based on non-clinical and clinical testing. For blood glucose monitoring systems, substantial equivalence often implies meeting the ISO 15197:2003 or later standards (or equivalent FDA guidance thresholds) for accuracy. However, without specific thresholds mentioned, we can only state that the device met the performance deemed substantially equivalent.

Acceptance Criteria Category	Specific Criteria (Explicit/Inferred)	Reported Device Performance
Non-Clinical Testing	- EMC and Electrical Safety compliant	"Results demonstrate substantial equivalence to the predicate system."
	- Drop testing robust	"Results demonstrate substantial equivalence to the predicate system."
	- Disinfection performance (robustness to multiple cleanings and disinfections) sufficient	"Results demonstrate substantial equivalence to the predicate system."
	- Software verification and validation (functional and reliable)	"Results demonstrate substantial equivalence to the predicate system."
	- Linearity testing with validation of Lo/Hi detection accurate	"Results demonstrate substantial equivalence to the predicate system."
Clinical Testing	- Ease-of-use (for self-testers)	"Results demonstrate substantial equivalence to the predicate system."
	- Ease-of-understanding of User's Manual	"Results demonstrate substantial equivalence to the predicate system."
Overall Performance	- Perform in a substantially equivalent manner to the predicate device (GAL-1C, K102816)	"Clinical and non-clinical testing demonstrated that the GAL-1A system performs in a substantially equivalent manner to that of the predicate."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the "user study" (clinical testing) or for the non-clinical tests (e.g., how many units were drop-tested, how many linearity measurements were taken, how many participants were in the user study). It only states "a user study was conducted."
Data Provenance: The manufacturing company, Apex Biotechnology Corp., is located in China (Taiwan). It is highly probable that the testing, both non-clinical and clinical, was conducted in Taiwan or a region accessible to them, but this is not explicitly stated. The document doesn't specify if the data was retrospective or prospective, but clinical "user studies" are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" for glucose levels is typically established by a laboratory reference method (e.g., YSI analyzer) rather than human experts interpreting results. The user study focused on "ease-of-use" and "ease-of-understanding," which would be evaluated by the target user population rather than highly specialized experts.

4. Adjudication Method for the Test Set

This information is not provided. Given that the clinical study was primarily a "user study" for ease-of-use and understanding, and analytical performance (accuracy) is typically compared against a reference lab method, a traditional multi-expert adjudication method (like 2+1 or 3+1) is unlikely to have been applied in the context usually seen with diagnostic image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human readers interpreting AI output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary evaluation of the device's core function (measuring blood glucose) is inherently a standalone performance assessment. The "GAL-1A meter uses the same test algorithm as the predicate meter," and its performance is compared to the predicate's established analytical accuracy through linearity testing. The "user study" then assesses the human-in-the-loop aspects of ease-of-use, but the core measurement is standalone.

7. The Type of Ground Truth Used

The ground truth for the analytical performance (glucose concentration measurement) would typically be established by a laboratory reference method (e.g., a YSI glucose analyzer) that is considered the gold standard for accurate glucose measurement. The documentation states "linearity testing with validation of Lo/Hi detection," which implicitly relies on comparison with such established reference values. For the user study, the "ground truth" for ease-of-use and understanding would be derived from user feedback and observational data.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device. The GAL-1A blood glucose meter uses an algorithm that is stated to be "the same test algorithm as the predicate meter." Blood glucose meters typically rely on electrochemical reactions and pre-calibrated algorithms, rather than machine learning models that require distinct "training sets" in the modern AI sense. The development of the algorithm for the predicate device would have involved calibration and validation data, but this wouldn't be referred to as a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The original algorithm for the predicate device would have been developed and calibrated using blood samples with glucose concentrations determined by a laboratory reference method, but the specifics of that process are not detailed for the GAL-1C device or its algorithm.

Summary

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K113208

JAN 2 6, 2012

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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: hsue-mei@apexbio.com
	Phone: 011-886-3-5641952
	FAX: 011-886-3-5678302
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 fortesting 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 GlucoseMonitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips, forearm, or palm.Alternative site testing should be performed only during steady-state (when glucoseis 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 inDiabetes Mellitus and should only be used by a single patient and it should not beshared. It is not indicated for the diagnosis or screening of diabetes or for neonataluse.
	GAL-1A Blood Glucose Test Strips: The GAL-1A Blood Glucose Test Strips are tobe used with the GAL-1A Blood Glucose Meter to quantitatively measure glucosein capillary whole blood taken from fingertips, palm, or forearm. Alternative sitetesting should be performed only during steady-state (when glucose is not changingrapidly). They are not indicated for the diagnosis or screening of diabetes or forneonatal use.
Comparison ofTechnologicalCharacteristics:	The GAL-1A meter has been modified relative to the predicate by orientingthe Liquid Crystal Display (LCD) vertically and rearranging its icons, plusaltering the meter case to accommodate the LCD change. The GAL-1Ameter uses the same test algorithm as the predicate meter. The GAL-1A teststrips are identical to their predicate devices.
Non-ClinicalTesting:	Testing was conducted as follows: EMC and Electrical Safety, drop testingdisinfection performance (robustness of meter to multiple cleanings anddisinfections), software verification and validation, and linearity testing withvalidation of Lo/Hi detection. Results demonstrate substantial equivalence tothe predicate system.
Clinical Testing	A user study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual. Results demonstrate substantialequivalence to the predicate system.
Conclusion:	Clinical and non-clinical testing demonstrated that the GAL-1A systemperforms in a substantially equivalent manner to that of the predicate. Weconclude that the GAL-1A meter and GAL-1A test strips are substantiallyequivalent 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 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).

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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 (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) 796-5760. 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 (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

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

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.