(469 days)
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No
The description details a standard electrochemical blood glucose monitoring system and a pedometer feature, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating or providing therapy directly.
Yes
The device is intended for the quantitative measurement of glucose and described as an "in vitro diagnostic only product," indicating its use in diagnosing or monitoring health conditions. While it explicitly states it is "NOT intended for the diagnosis or screening of diabetes," its function in aiding the monitoring of diabetes management still places it within the realm of diagnostic devices used for ongoing health assessment.
No
The device description explicitly mentions "The meter measures the current, calculates your blood glucose level, and displays your blood glucose test result," indicating a physical meter component is part of the system, not just software. The performance studies also refer to "the Gmate® mini / Gmate® STEP Systems" and comparisons to a laboratory instrument, further suggesting a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The Intended Use and Device Description sections both explicitly state that the device is intended for "in vitro diagnostic use only".
- Measurement of Biological Sample: The device measures glucose in "fresh capillary whole blood samples", which is a biological sample taken from the body.
- Purpose of Measurement: The measurement is used "as an aid to monitor the effectiveness of their diabetes management", which is a diagnostic purpose (monitoring a disease state).
- Test Principle: The description of the test principle clearly outlines an in vitro chemical reaction and electrochemical measurement performed on the blood sample outside the body.
N/A
Intended Use / Indications for Use
The Gmate® mini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh or calf. The Gmate® mini Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.
The Gmate® mini Blood Glucose Monitoring 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 Gnate® mini Blood Glucose Monitoring System is NOT intended for the diagnosis 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® mini Blood Glucose Monitoring System only 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® STEP Blood Glucose Monitoring System is intended to be used 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® STEP Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.
The Gmate® STEP Blood Glucose Monitoring 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 Gnate® STEP Blood Glucose Monitoring System is NOT intended for the diagnosis 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® STEP includes a pedometer feature that allows the user to count the number of steps they take.
The Gmate® Blood Glucose Test Strips are for use with the Gmate® STEP Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are 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 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, calculates your blood glucose level, and displays your blood glucose test result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
fingertips, forearm, upper arm, palm, thigh or calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use only) 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical and clinical tests for the Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System were performed in accordance with ISO15197 and other 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® mini and the Gmate® STEP Systems. The evaluations of the Gmate® mini / Gmate® STEP Systems were 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® mini / Gmate® STEP devices 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2015
PHILOSYS, INC. C/O LINDA CHAN MANAGING DIRECTOR 304 PARK AVENUE SOUTH, SUITE 218 NEW YORK NY 10010
Re: K141656
Trade/Device Name: Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: September 25, 2015 Received: September 28, 2015
Dear Ms. 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/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
2
Indications for Use
510(k) Number (if known) K141656
Device Name
Gmate® mini Blood Glucose Monitoring System
Indications for Use (Describe)
The Gmate® mini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh or calf. The Gmate® mini Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.
The Gmate® mini Blood Glucose Monitoring 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 Gnate® mini Blood Glucose Monitoring System is NOT intended for the diagnosis 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® mini Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
| 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.
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.gov
"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."
3
Indications for Use
510(k) Number (if known) K141656
Device Name
Gmate® STEP Blood Glucose Monitoring System
Indications for Use (Describe)
The Gmate® STEP Blood Glucose Monitoring System is intended to be used 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® STEP Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.
The Gmate® STEP Blood Glucose Monitoring 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 Gnate® STEP Blood Glucose Monitoring System is NOT intended for the diagnosis 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® STEP includes a pedometer feature that allows the user to count the number of steps they take.
The Gmate® Blood Glucose Test Strips are for use with the Gmate® STEP Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
| 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 NEEDEDThis 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.gov
"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."
4
osys, Inc.
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 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)
| Manufacturer Name: | Philosys Co. Ltd. 827-3Sanpyuung-ri, Okgu-eup, Gunsan-si Jeollabuk-do, 573-901 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 304 Park Avenue South Suite 218 New York, NY 10010 |
| Phone: | 646-454-5414 |
| Fax: | 646-454-5454 |
| Email: | lchan@usdiagnostics.net |
| Date Summary, Prepared: | June 17, 2014 |
| Device Name: | Propriety Name: Gmate® mini Blood Glucose Monitoring System Gmate® STEP Blood Glucose Monitoring System |
| Model Number: | PG-200 / PG-201 |
| Common Name: | Blood Glucose Test System, Blood Glucose Monitoring System |
| Classification Name: | Blood Glucose, Test, System, Glucose Oxidase, over the counter |
| Class: | II |
| Product Code: | CGA, NBW |
| Classification Regulation: | 21 CFR 862.1345 |
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New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 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) K083468 - I-SENS, Inc. CareSens N Blood Glucose Monitoring System Device Description: The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are 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 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, calculates your blood glucose level, and displays your blood glucose test result.
Intended Use for Gmate® mini:
The Gmate® mini Blood Glucose Monitoring System is intended to be used 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® mini Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.
The Gmate® mini Blood Glucose Monitoring 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® mini Blood Glucose Monitoring System is NOT intended for the diagnosis 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® mini Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
6
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 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 for Gmate® STEP:
The Gmate® STEP Blood Glucose Monitoring System is intended to be used 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® STEP Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.
The Gmate® STEP Blood Glucose Monitoring 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® STEP Blood Glucose Monitoring System is NOT intended for the diagnosis 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® STEP includes a pedometer feature that allows the user to count the number of steps they take.
The Gmate® Blood Glucose Test Strips are for use with the Gmate® STEP Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
Comparison to Predicate Device:
The indications for use and the scientific technology of the Gmate® mini Blood Glucose Monitoring System, the Gmate® STEP Blood Glucose Monitoring System and the predicate device are similar. The assay method, detection method, enzyme, mediator, test time, calibration, glucose unit, and battery life of the Gmate® mini and Gmate® STEP systems are exactly the same as the predicate device. There are few items of the specifications such as test range, storage conditions, temperature, size, weight and modes that will differ.
As shown in the summary performance testing data of the clinical and nonclinical comparison, it demonstrated that those differences do not raise issues of safety and effectiveness. Therefore, based on the information provided in this Premarket notification, we conclude the Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are safe, effective, and substantially equivalent to the predicate device as described herein.
7
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 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)
Non-clinical and clinical tests for the Gmate® mini Blood Glucose Monitoring Performance Data: System and the Gmate® STEP Blood Glucose Monitoring System were performed in accordance with ISO15197 and other 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® mini and the Gmate® STEP Systems. The evaluations of the Gmate® mini / Gmate® STEP Systems were 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® mini / Gmate® STEP devices 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. Conclusion: The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are safe, as effective, and is substantially equivalent to the K083468 - I-SENS, Inc. CareSens N Blood Glucose Monitoring System.