(286 days)
Not Found
No
The description focuses on electrochemical measurement and data display/storage via a smartphone app. There is no mention of AI or ML for analysis, prediction, or interpretation of the glucose data beyond simple graphing and trending.
No.
The device is for monitoring glucose levels, not for therapy or treatment. Its intended use is for "in vitro diagnostic use" to "monitor the effectiveness of diabetes control."
No
The Gmate® SMART Blood Glucose Monitoring System is explicitly stated "should not be used for the diagnosis of or screening of diabetes". It is intended for monitoring the effectiveness of diabetes control by people already diagnosed with diabetes.
No
The device description explicitly states that the system consists of a glucose meter, test strips, and control material, in addition to the software application. The meter is a physical hardware component that measures the electrical current generated by the test strip.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "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..."
- Device Description: The "Device Description" section also reiterates this: "The Gmate® SMART System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home..."
- Test Principle: The "Device Description" further clarifies the test principle: "This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood."
- Function: The device measures glucose in a biological sample (blood) outside of the body to provide information about a person's health status (diabetes management). This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW, CGA, JOP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, palm, thigh or calf, upper arm
Indicated Patient Age Range
The Gmate® SMART should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical and clinical tests for the Gmate® SMART Blood Glucose System were performed in accordance with FDA Guidance Documents and CLSI reference standards. The clinical performance evaluation testing included system accuracy, user performance, and alternative-site blood glucose measurement. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K150299
Device Name
The Gmate® SMART Blood Glucose Monitoring System
Indications for Use (Describe)
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.
| 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) |
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3
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-ri
Jeollabuk-do, 573-907 Republic of Korea | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------|
| | Phone: +82-63-453-1421
Fax: +82-63-453-1423
Contact: Byeong-Kyu Kim (Email: bkkim@philosys.com) | | |
| Submitted By: | Linda Chan
Philosys
711 Third Avenue
Suite 1502
New York, NY 10017 | | |
| Contact Person: | Linda Chan
Phone: 645-454-5414
Fax: 646-400-5240
Email: lchan@usdiagnostics.net | | |
| Date Summary, Prepared: | February 3, 2015 | | |
| Device Name: | Propriety Name:
Gmate® SMART Blood Glucose Monitoring System
Model Number: PG-101
Common Name: Blood Glucose Test System, Blood Glucose Monitoring System
Classification Name: Blood Glucose, Test, System, Glucose Oxidase, over counter | | |
| Product Code | Classification | Regulation Section | Panel |
| Product
| Code | 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) |
4
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. |
5
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 the
quantitative measurement of glucose (sugar) in fresh capillary whole blood
samples drawn from the fingertips, forearm, upper arm, 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 for use 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. |
| Comparison to
Predicate Device: | The Gmate® SMART Blood Glucose Monitoring System (including meter,
control solutions, and test strips) is currently approved under K131230. Under
K131230, the Gmate® SMART was only compatible and approved to be used
with the Apple iOS devices. |
| | This new 510(k) is to update the previous submission with additional
compatible devices; the Android mobile smartphones. |
| | The studies and reports provided show that the Android devices with the
Gmate® SMART BGMS are as equivalent, safe, and effective as approved
under K131230. |
| Performance Data: | Non-clinical and clinical tests for the Gmate® SMART Blood Glucose System
were performed in accordance with FDA Guidance Documents and CLSI
reference standards. |
| | The clinical performance evaluation testing included system accuracy, user
performance, and alternative-site blood glucose measurement. |
6
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.