The GDH Professional LED Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh, and venous whole blood. The GDH Professional LED Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional LED Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional test strips are for use with the GDH Professional LED meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GDH Professional control solutions are for use with the GDH Professional LED meter and GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GDH Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and venous whole blood. The GDH Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional test strips are for use with the GDH Professional meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GDH Professional control solutions are for use with the GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are in vitro diagnostic devices designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

AI/ML Overview

This 510(k) summary does not contain the detailed acceptance criteria or study results needed to complete the requested table and answer all questions directly. It provides a high-level statement that "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not specify the numerical criteria, the reported device performance against those criteria, or the details of the studies conducted.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that "The device passed all of the tests based on pre-determined Pass/Fail criteria," but does not list these criteria or the specific performance metrics achieved. For a blood glucose monitoring system, typical acceptance criteria would be based on ISO 15197 (e.g., percentage of results within ±15% or ±20% of a reference method).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document mentions "Verification, validation and testing activities" but does not specify the sample size for any of these tests or the origin/type of data (retrospective/prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable/provided in the context of a blood glucose monitoring system's analytical performance testing. Ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., YSI instrument), not by expert consensus or interpretation of images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads), not for objective measurements by a device like a blood glucose meter.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to diagnostic imaging and AI applications, not to the performance assessment of a blood glucose monitoring system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone system for measuring glucose. There is no "human-in-the-loop" component in terms of interpretive performance that would require this type of study. The study implies an evaluation of the device's accuracy against a reference method, which is inherently standalone performance. However, the details of this standalone performance are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not explicitly stated but can be inferred. For a blood glucose monitoring system, the "ground truth" or reference method is typically a laboratory-grade analyzer (e.g., YSI). The document mentions "analytical performance," which strongly implies comparison to a highly accurate reference method.

8. The sample size for the training set:

This information is not applicable/provided. Blood glucose monitoring systems, as described, do not typically involve "training sets" in the machine learning sense. Their calibration and performance are based on chemical and electrochemical principles, and physical calibration processes, rather than on algorithm training with large datasets.

9. How the ground truth for the training set was established:

This information is not applicable/provided for the reasons stated above.

Summary of available information:

Device Name: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
Indication for Use: Quantitative measurement of glucose in capillary and venous whole blood for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of a diabetes control program. Not for diagnosis, screening, or neonatal use.
Study Type: The document states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies analytical accuracy, precision, and robustness testing. Additionally, a Disinfection Study and a Robustness Study were performed.
Predicate Device: GluNEOTM Lite Professional Blood Glucose Monitoring System (K132966) by Infopia Co., Ltd.
Conclusion: The device is substantially equivalent to the predicated device based on verification/validation activities.

Missing Key Information for a Comprehensive Answer:

To fully answer your request, detailed study reports providing the following would be needed:

Specific analytical accuracy and precision criteria (e.g., according to ISO 15197)
The actual performance results of the device against those criteria (percentage within specific error limits).
The exact sample sizes (number of subjects, number of samples per subject) used in performance studies.
The specific reference method used for ground truth (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer).
Details of the collected data (e.g., glucose range covered, patient demographics).

Summary

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

Auqust 26, 2015

INFOPIA CO., LTD. C/O PRISCILLA CHUNG REGULATORY AFFAIRS CONSULTANT 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92833

Re: K150274

Trade/Device Name: GDH Professional Blood Glucose Monitoring System GDH Professional LED Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: July 22, 2015 Received: July 27, 2015

Dear Priscilla Chung:

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 (QS) 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Katherine Serrano -S

For : 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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Indications for Use

510(k) Number (if known) K150274

Device Name

GDH Professional LED Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Services (301) 443-6740

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Indications for Use

510(k) Number (if known) K150274

Device Name

GDH Professional Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary (K150274)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 08/24/2015

1. Applicant / Submitter:

Infopia Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang, Gyeonggi-do, Republic of Korea 431-836 Tel : +82-31-460-0415 Fax : +82-31-460-0403

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Trade Name: GDH Professional Blood Glucose Monitoring System GDH Professional LED Blood Glucose Monitoring System
· Classification Name: Glucose test system. Ouality control material (assayed and unassayed)
Classification regulation: 21 CFR Part 862.1345, 21 CFR Part 862.1660
" Product Code: NBW, LFR, JJX

4. Predicate Device:

GluNEOTM Lite Professional Blood Glucose Monitoring System(K132966) by Infopia Co., Ltd.

5. Description:

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6. Indications for use:

GDH Professional Blood Glucose Monitoring System

The GDH Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh, and venous whole blood. The GDH Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional control solutions are for use with the GDH Professional meter and GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GDH Professional LED Blood Glucose Monitoring System

The GDH Professional LED Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh, and venous whole blood. The GDH Professional LED Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GDH Professional LED Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

7. Comparison to the Cleared Device

The modifications are the changes in meter appearance, battery quantity, LCD display type and LED light (only for GDH Professional LED) and icon display.

Other than these modifications, the modified meter has the following similarities to the cleared device:

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· has the same intended use,
· uses the same operating principle,
· adopts the same use environment and calibration method.

8. Performance Data

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter.

Robustness Study: Based on the outcome of the robustness study designed to mimic 3 years' rigorous repetition of cleaning and disinfection procedures, it is confirmed that GDH Professi onal LED System is robust in maintaining its appearance, operational functions and analytical performance.

9. Conclusion

The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated device.

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.