(165 days)
No
The summary describes a standard electrochemical blood glucose monitoring system that measures current generated by a chemical reaction. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
A therapeutic device is one that treats a disease or condition. This device is a diagnostic tool used to measure blood glucose levels, aiding in the monitoring of diabetes but not directly treating it.
Yes
The device measures glucose levels to monitor the effectiveness of diabetes control, which is a form of diagnostic aid. However, it explicitly states it should not be used for "diagnosis of or screening of diabetes". This indicates it is a monitoring device but not a primary diagnostic device for identifying the disease. For the purpose of this question where "diagnostic device" means any device that helps in diagnosis or management of a condition, monitoring blood glucose to manage diabetes fits.
No
The device description explicitly states that the system consists of a glucose meter, test strips, and control material, which are all hardware components. The test principle also describes a chemical reaction on a test strip and a meter measuring electrical current, indicating a physical device is involved.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Gmate® Origin Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..."
- Device Description: The "Device Description" section also reiterates: "The Gmate® Origin System is intended for self-testing outside the body (in vitro diagnostic use only)..."
- Test Principle: The "Test principle" section describes the mechanism of action, which involves a chemical reaction on a test strip using a blood sample, which is characteristic of in vitro diagnostics.
The device is designed to test a biological sample (blood) outside the body to provide diagnostic information (glucose levels), which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gmate® Origin 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® Origin Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® Origin Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Gmate® Origin Glucose Monitoring System 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® Origin Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, thigh or calf.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The Gmate® Origin Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® Origin 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® Origin 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 Gmate® Origin Blood Glucose Monitoring System do not require coding or calibration and uses 1 CR2032 (Lithium Ion Battery). Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds countdown to display the test result.
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 ar electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level.
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
Not Found
Intended User / Care Setting
Used by a single person, 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® Origin Blood Glucose Monitoring 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® Origin System. The evaluations of the Gmate® Origin 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® Origin 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.
K083468 – I-SENS, Inc. CareSens N Blood Glucose Monitoring System
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.
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).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2015
PHILOSYS, INC. LINDA CHAN MANAGER 304 PARK AVENUE SOUTH, SUITE 218 NEW YORK NY 10016
Re: K151658
Trade/Device Name: Gmate® Origin Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: October 14, 2015 Received: October 15, 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) K151658
Device Name
Gmate® Origin Blood Glucose Monitoring System
Indications for Use (Describe)
The Gmate® Origin 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® Origin Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® Origin Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Gmate® Origin Glucose Monitoring System 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® Origin Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, 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) |
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3
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)
(As required by 21CFR807.92)
| 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 ) |
| 510(k) Submitter
and Correspondent: | Linda Chan
Philosys
711 Third Avenue, Suite 1502
New York, NY 10017 |
| | Phone: 646-454-5414
Fax: 646-400-5240
Email: lchan@usdiagnostics.net |
| Date Summary,
Prepared: | June 16, 2015 |
| Device Name: | Propriety Name:
Gmate ® Origin Blood Glucose Monitoring System |
| | Model Number: PG-310 |
| | Common Name: Blood Glucose Test System, Blood Glucose Monitoring
System |
| | Classification Name: Blood Glucose, Test, System, Glucose Oxidase, over the
counter |
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| CGA | II | 21 CFR 862.1345 | Chemistry (75) |
| NBW | II | 21 CFR 862.1345 | Chemistry (75) |
Predicate Device:
We claim substantial equivalence to:
- K083468 - I-SENS, Inc. CareSens N Blood Glucose Monitoring System
4
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)
| Device Description: | The Gmate® Origin Blood Glucose Monitoring System is intended to be used
for the quantitative measurement of glucose (sugar) in fresh capillary whole
blood. The Gmate® Origin 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® Origin 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 Gmate® Origin Blood Glucose
Monitoring System do not require coding or calibration and uses 1 CR2032
(Lithium Ion Battery). Insert the test strip into the meter, apply the blood or
control solution to the strip and the meter will begin the 5 seconds countdown
to display the test result.
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 ar
electrochemical signal generating an electrical current that will stimulate a
chemical reaction. The meter measures the current and calculates your blood
glucose level. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Gmate® Origin 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® Origin Blood Glucose Monitoring System is intended to be used
by a single person and should not be shared.
The Gmate® Origin Blood Glucose Monitoring System is intended for self-
testing outside the body (in vitro diagnostic use) by people with diabetes an
home as an aid to monitor the effectiveness of diabetes control. The Gmate®
Origin Glucose Monitoring System 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® Origin
Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh
capillary whole blood samples drawn from the fingertips, forearm, upper arm,
palm, thigh or calf. |
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)
| Comparison to Predicate Device: | The indications for use and the scientific technology of the Gmate® Origin 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® Origin system 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 non-clinical 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® Origin Blood Glucose Monitoring System is safe, effective, and substantially equivalent to the predicate device as described herein. The Gmate® Control Solution has been previous approved under K131230. |
|---|---|
| Performance Data: | Non-clinical and clinical tests for the Gmate® Origin Blood Glucose Monitoring 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® Origin System. The evaluations of the Gmate® Origin 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® Origin 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® Origin Blood Glucose Monitoring System is safe and effective and substantially equivalent to K083468 – I-SENS, Inc. CareSens N Blood Glucose Monitoring System. |