The Gmate® SMART Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, thigh or calf. The Gmate® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Gmate® SMART should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).

The Gmate® Blood Glucose Test Strips are with the GMATE® SMART meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.

The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management.

Device Description

The Gmate® SMART Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® SMART System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® SMART Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The small Gmate® SMART meter does not require coding or calibration, no need of batteries, and no settings are required. The Gmate® SMART meter is powered on by plugging it into the headphone jack of the Apple/Android device. Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds count down of your test result. The Gmate™ SMART App converts the signal generated from the meter and test strip and displays the test result on the Apple/Android device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently with Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4th generation, iPad, and iPad2) and now with the following Android devices: Samsung Galaxy S3, S4, and S5; to view glucose test results. A simple download of the Gmate® SMART App, enables use of many functions. The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider or healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management. The test principle is: This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level. Combined with the Gmate™ SMART App, it displays the test result and stores them on your Apple/Android device.

AI/ML Overview

Here’s an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for accuracy. However, it does state an overall conclusion: "The results demonstrated that the Gmate® SMART met all the reliability requirements and performance claims." and "Based on the comparisons completed of the clinical and non-clinical tests performed, the devices passed all of the tests based on pre-determined Pass/Fail Criteria."

To infer the acceptance criteria for accuracy, we typically refer to ISO 15197 for blood glucose monitoring systems. While not directly stated, the study implies adherence to these standards by mentioning "FDA Guidance Documents and CLSI reference standards." The YSI 2300 Glucose Analyzer is the widely accepted reference method for accuracy in these types of studies. The performance is reported as meeting "all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria."

Performance Metric	Acceptance Criteria (Inferred from regulatory standards)	Reported Device Performance
System Accuracy	Typically based on ISO 15197 (e.g., >95% of results within ±15 mg/dL or ±15% of reference for specific glucose ranges)	"Met all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria."
Precision	Not explicitly defined, but implied by "passed all of the tests"	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
Linearity	Not explicitly defined, but implied by "passed all of the tests"	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
Interference	Not explicitly defined, but implied by "passed all of the tests"	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
Hematocrit	Not explicitly defined, but implied by "passed all of the tests"	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
Altitude	Not explicitly defined, but implied by "passed all of the tests"	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
Temperature/Humidity	Not explicitly defined, but implied by "passed all of the tests"	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
User Performance	Successful completion of tests by users	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"
Alternate Site Testing	Successful completion of tests	"Evaluations... conducted to establish the performance, the functionality and the reliability characteristics"

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

Sample Size for Test Set: "Glucose levels were measured on 100 persons with diabetes and healthcare professionals at a clinic center."
Data Provenance: The document does not explicitly state the country of origin where the clinical study took place. It mentions Philosys, Inc. has a New York Office and a Seoul Office (South Korea). It also states "clinical tests... were performed in accordance with FDA Guidance Documents and CLSI reference standards," which suggests the study was designed to meet US regulatory requirements. The study appears to be prospective as it involves performance evaluations on individuals, rather than analyzing existing datasets.

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):

The ground truth was established using the YSI 2300 Glucose Analyzer, a laboratory instrument.
The document mentions "healthcare professionals at a clinic center" were involved in measuring glucose levels, but it doesn't specify the number or specific qualifications of these professionals for establishing the ground truth. Their role was likely to operate the YSI 2300 and collect samples, not to interpret or adjudicate results in the way an "expert" would for image-based diagnostics.

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

No adjudication method (like 2+1 or 3+1 consensus) is described. This is expected for a blood glucose monitoring system where the YSI 2300 Glucose Analyzer itself serves as the objective reference standard, not human interpretation.

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:

No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices (e.g., radiology AI) where human readers make diagnoses. The Gmate® SMART is a quantitative measurement device, not an interpretative one in the sense of an MRMC study.

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

Yes, a standalone performance evaluation was done. The device's accuracy was assessed by comparing its glucose readings directly against a laboratory reference instrument (YSI 2300 Glucose Analyzer). While users operate the device, the core performance being evaluated is the algorithm/system's ability to accurately measure glucose, independent of human interpretive bias. The study also included "user performance" which might incorporate human interaction, but the primary accuracy assessment is standalone.

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

The ground truth used was reference laboratory measurement from a YSI 2300 Glucose Analyzer. This is considered a highly accurate and objective standard for glucose concentration.

8. The sample size for the training set:

The document does not provide information about a training set. This is common for this type of device, where analytical and clinical performance studies are conducted, rather than machine learning model training in the typical sense. The device's underlying measurement principle is electrochemical, not a learned algorithm requiring a separate training set.

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

As no training set is mentioned or implied, this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

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

November 19, 2015

PHILOSY'S INC. LINDA CHAN MANAGING DIRECTOR 304 PARK AVENUE SOUTH, SUITE 218 NEW YORK NY 10010

Re: K150299

Trade/Device Name: The Gmate® SMART Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JOP Dated: November 11, 2015 Received: November 12, 2015

Dear Linda Chan:

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/Resourcesfor You/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) K150299

Device Name

The Gmate® SMART 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)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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philosys, Inc.

New York Office 711 Third Avenue Suite 1502 New York, NY 10017 USA TEL: 855-GO-GMATE FAX: 800-939-8670

Seoul Office

635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423

over the

510(k) SUMMARY

(As required by 21.CFR.807.92)

Manufacturer Name:	Philosys Co. Ltd.827-3Sanpyeong-ri, Okgu-eup, Gunsan-riJeollabuk-do, 573-907 Republic of Korea
	Phone: +82-63-453-1421Fax: +82-63-453-1423Contact: Byeong-Kyu Kim (Email: bkkim@philosys.com)
Submitted By:	Linda ChanPhilosys711 Third AvenueSuite 1502New York, NY 10017
Contact Person:	Linda ChanPhone: 645-454-5414Fax: 646-400-5240Email: lchan@usdiagnostics.net
Date Summary, Prepared:	February 3, 2015
Device Name:	Propriety Name:Gmate® SMART Blood Glucose Monitoring SystemModel Number: PG-101Common Name: Blood Glucose Test System, Blood Glucose Monitoring SystemClassification Name: Blood Glucose, Test, System, Glucose Oxidase, over counter
Product Code	Classification	Regulation Section	Panel

ProductCode	Classification	Regulation Section	Panel
CGA	II	21 CFR 862.1345	Chemistry (75)
NBW	II	21 CFR 862.1345	Chemistry (75)
JQP	I	21 CFR 862.2100	Chemistry (75)

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sus, Inc.

New York Office 711 Third Avenue Suite 1502 New York, NY 10017 USA TEL: 855-GO-GMATE FAX: 800-939-8670

Seoul Office

635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423

510(k) SUMMARY (As required by 21.CFR.807.92)

Predicate Device:	We claim substantial equivalence to: 1) K131230- Gmate® SMART Blood Glucose Monitoring System
Device Description:	The Gmate® SMART Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® SMART System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® SMART Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The small Gmate® SMART meter does not require coding or calibration, no need of batteries, and no settings are required. The Gmate® SMART meter is powered on by plugging it into the headphone jack of the Apple/Android device. Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds count down of your test result. The Gmate™ SMART App converts the signal generated from the meter and test strip and displays the test result on the Apple/Android device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently with Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4th generation, iPad, and iPad2) and now with the following Android devices: Samsung Galaxy S3, S4, and S5; to view glucose test results. A simple download of the Gmate® SMART App, enables use of many functions. The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider or healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management. The test principle is: This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level. Combined with the Gmate™ SMART App, it displays the test result and stores them on your Apple/Android device.

Predicate Device:

We claim substantial equivalence to: 1) K131230- Gmate® SMART Blood Glucose Monitoring System

Device Description:

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philosys, Inc.

New York Office 711 Third Avenue Suite 1502 New York, NY 10017 USA TEL: 855-GO-GMATE FAX: 800-939-8670

Seoul Office

635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423

510(k) SUMMARY

(As required by 21.CFR.807.92)

Intended Use:	The Gmate® SMART Blood Glucose Monitoring System is intended for thequantitative measurement of glucose (sugar) in fresh capillary whole bloodsamples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.The Gmate® SMART Blood Glucose Monitoring System is intended to beused by a single person and should not be shared.
	The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes athome to monitor the effectiveness of diabetes control. The Gmate® SMARTshould not be used for the diagnosis of or screening of diabetes or for neonataluse. Alternate site testing should be done only during steady state times (whenglucose is not changing rapidly).
	The Gmate® Blood Glucose Test Strips are for use with the GMATE®SMART meter to quantitatively measure glucose (sugar) in fresh capillarywhole blood samples drawn from the fingertips, forearm, upper arm, palm,thigh or calf.
	The Gmate™ SMART App is a component of the Gmate® SMART BloodGlucose Monitoring System and is intended to be used by people with diabetesat home as an aid to monitor and track the effectiveness of their diabetesmanagement. The Gmate™ SMART App allows the user to view their glucosetest results and store a lifetime of results. The user may e-mail their glucosetest results to their healthcare provider to help them review, analyze, andevaluate their glucose test results to support an effective diabetes managementprogram. The user can also graph and trend their glucose test results to providean outlook of their diabetes management.
Comparison toPredicate Device:	The Gmate® SMART Blood Glucose Monitoring System (including meter,control solutions, and test strips) is currently approved under K131230. UnderK131230, the Gmate® SMART was only compatible and approved to be usedwith the Apple iOS devices.
	This new 510(k) is to update the previous submission with additionalcompatible devices; the Android mobile smartphones.
	The studies and reports provided show that the Android devices with theGmate® SMART BGMS are as equivalent, safe, and effective as approvedunder K131230.
Performance Data:	Non-clinical and clinical tests for the Gmate® SMART Blood Glucose Systemwere performed in accordance with FDA Guidance Documents and CLSIreference standards.
	The clinical performance evaluation testing included system accuracy, userperformance, and alternative-site blood glucose measurement.

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New York Office 711 Third Avenue Suite 1502 New York, NY 10017 USA TEL: 855-GO-GMATE FAX: 800-939-8670

Seoul Office 635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421

FAX: +82-2-553-1423

510(k) SUMMARY

(As required by 21.CFR.807.92)

The non-clinical performance evaluation testing included precision, linearity, interference, hematocrit, altitude, and temperature/humidity. These evaluations were conducted to establish the performance, the functionality and the reliability characteristics of the Gmate® SMART Blood Glucose System.

The evaluations of the Gmate® SMART System was assessed by comparing blood glucose results obtained by patients with those obtained using the YSI 2300 Glucose Analyzer, a laboratory instrument. Glucose levels were measured on 100 persons with diabetes and healthcare professionals at a clinic center.

No adverse events occurred during the studies. The results demonstrated that the Gmate® SMART met all the reliability requirements and performance claims.

Based on the comparisons completed of the clinical and non-clinical tests performed, the devices passed all of the tests based on pre-determined Pass/Fail Criteria.

The Gmate SMART Blood Glucose Monitoring System is safe and effective Conclusion: and substantially equivalent to K131230 - Gmate® SMART Blood Glucose Monitoring System.

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.