(165 days)
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.
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.
The document provided describes the Gmate® Origin Blood Glucose Monitoring System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose meters typically follow ISO 15197 standards. While the specific numerical thresholds for each criterion are not explicitly stated in this document, it refers to "pre-determined Pass/Fail Criteria" and meeting "all the reliability requirements and performance claims." The performance is compared against the YSI 2300 Glucose Analyzer as a reference.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| System Accuracy | Demonstrated to meet reliability requirements and performance claims. |
| User Performance | Demonstrated to meet reliability requirements and performance claims. |
| Alternate-Site Blood Glucose Measurement | Demonstrated to meet reliability requirements and performance claims. |
| Precision | Passed test based on pre-determined Pass/Fail Criteria. |
| Linearity | Passed test based on pre-determined Pass/Fail Criteria. |
| Interference | Passed test based on pre-determined Pass/Fail Criteria. |
| Hematocrit | Passed test based on pre-determined Pass/Fail Criteria. |
| Altitude | Passed test based on pre-determined Pass/Fail Criteria. |
| Temperature/Humidity | Passed test based on pre-determined Pass/Fail Criteria. |
Note: The document states that the device "met all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria." However, the exact numerical acceptance limits and detailed results (e.g., percentage within ±15% or ±20% of reference) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Providence
- Sample Size for Test Set: 100 persons.
- Data Provenance: The study involved 100 persons with diabetes and healthcare professionals "at a clinic center." The manufacturer's address includes "Republic of Korea" and "New York, NY, USA." Without further detail, it's not definitively clear if the clinical testing was conducted in Korea, the USA, or both. The study appears to be prospective as it involved measurements "obtained by patients with those obtained using the YSI 2300 Glucose Analyzer."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions that the test set data was collected from "100 persons with diabetes and healthcare professionals at a clinic center." The ground truth was established by comparing the device readings to results from a "YSI 2300 Glucose Analyzer, a laboratory instrument." The YSI 2300 is a highly accurate laboratory reference method for glucose measurement, and its calibration and operation would typically be performed by trained laboratory technicians or clinical staff, who could be considered experts in reference glucose measurement. However, the exact number and specific qualifications of the experts directly involved in establishing the "ground truth" (i.e., operating the YSI analyzer and interpreting its results for the study) are not specified.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. Instead, it directly compares the Gmate® Origin readings to the laboratory reference standard (YSI 2300 Glucose Analyzer). Adjudication methods are more commonly used in studies involving subjective interpretations (e.g., medical imaging) to resolve discrepancies between readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or designed for this device. This type of study focuses on the diagnostic accuracy of human readers with and without AI assistance, which is generally not applicable to a blood glucose monitoring system that provides a direct numerical reading. The study focuses on the accuracy of the device itself compared to a reference standard.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "clinical performance evaluation testing included system accuracy, user performance, and alternative-site blood glucose measurement." These evaluations assessed the Gmate® Origin system's performance by comparing its readings directly with those obtained from the YSI 2300 Glucose Analyzer. This is a standalone evaluation of the algorithm/device as it functions independently to provide a glucose reading.
7. Type of Ground Truth Used
The type of ground truth used was a laboratory reference method – specifically, the YSI 2300 Glucose Analyzer. This is considered a highly accurate and reliable method for determining blood glucose concentration.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. It primarily describes the performance evaluation studies. For devices like blood glucose meters with electrochemical principles, extensive "training data" in the AI/machine learning sense is not typically a primary component of their development and validation as it would be for pattern recognition or image analysis algorithms. Instead, their development relies on chemical and electrochemical engineering, and their validation on analytical performance studies. If there were any internal calibration or algorithm refinement using data, that information is not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
As noted above, information about a "training set" in the context of machine learning (and its associated ground truth) is not provided. The development and validation of this device likely relied on standard analytical chemistry and engineering principles, with performance validated through clinical and non-clinical studies against a laboratory reference.
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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.
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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) 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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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-riJeollabuk-do, 573-907 Republic of Korea |
|---|---|
| Phone: +82-63-453-1421Fax: +82-63-453-1423Contact: Byeong-Kyu Kim (Email: bkkim@philosys.com ) | |
| 510(k) Submitterand Correspondent: | Linda ChanPhilosys711 Third Avenue, Suite 1502New York, NY 10017 |
| Phone: 646-454-5414Fax: 646-400-5240Email: 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 MonitoringSystem | |
| Classification Name: Blood Glucose, Test, System, Glucose Oxidase, over thecounter |
| 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
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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)
| Device Description: | The Gmate® Origin Blood Glucose Monitoring System is intended to be usedfor the quantitative measurement of glucose (sugar) in fresh capillary wholeblood. 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 tomonitor the effectiveness of their diabetes management.The Gmate® Origin Blood Glucose Monitoring System consists of a glucosemeter, test strips, and one control material (additional levels of controlmaterial are available upon request). The Gmate® Origin Blood GlucoseMonitoring System do not require coding or calibration and uses 1 CR2032(Lithium Ion Battery). Insert the test strip into the meter, apply the blood orcontrol solution to the strip and the meter will begin the 5 seconds countdownto display the test result.The test principle is:This device is an in vitro diagnostic only product intended for themeasurement of glucose concentration in human blood. The principle of thetest relies upon a specific type of glucose in the blood sample, the glucoseoxidase that reacts to electrodes in the test strip. The test strip employs arelectrochemical signal generating an electrical current that will stimulate achemical reaction. The meter measures the current and calculates your bloodglucose level. |
|---|---|
| Intended Use: | The Gmate® Origin 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® Origin Blood Glucose Monitoring System is intended to be usedby 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 anhome as an aid to monitor the effectiveness of diabetes control. The Gmate®Origin Glucose Monitoring System should not be used for the diagnosis of orscreening of diabetes or for neonatal use. Alternate site testing should be doneonly during steady-state times (when glucose is not changing rapidly).The Gmate® Blood Glucose Test Strips are for use with the Gmate® OriginBlood Glucose Meter to quantitatively measure glucose (sugar) in freshcapillary whole blood samples drawn from the fingertips, forearm, upper arm,palm, thigh or calf. |
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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)
| 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. |
§ 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.