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510(k) Data Aggregation
K Number
K151658Device Name
Gmate Origin Blood Glucose Monitoring System
Manufacturer
Philosys Inc.
Date Cleared
2015-12-01
(165 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Philosys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, 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.
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.
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K Number
K150299Device Name
Gmate SMART Blood Glucose Monitoring System
Manufacturer
Philosys Inc.
Date Cleared
2015-11-19
(286 days)
Product Code
NBW, CGA, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Philosys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, palm, thigh or calf. The Gmate® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Gmate® SMART should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).
The Gmate® Blood Glucose Test Strips are with the GMATE® SMART meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management.
Device Description
The Gmate® SMART Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® SMART System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® SMART Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The small Gmate® SMART meter does not require coding or calibration, no need of batteries, and no settings are required. The Gmate® SMART meter is powered on by plugging it into the headphone jack of the Apple/Android device. Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds count down of your test result. The Gmate™ SMART App converts the signal generated from the meter and test strip and displays the test result on the Apple/Android device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently with Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4th generation, iPad, and iPad2) and now with the following Android devices: Samsung Galaxy S3, S4, and S5; to view glucose test results. A simple download of the Gmate® SMART App, enables use of many functions. The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider or healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management. The test principle is: This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level. Combined with the Gmate™ SMART App, it displays the test result and stores them on your Apple/Android device.
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K Number
K141656Device Name
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Philosys Inc.
Date Cleared
2015-10-02
(469 days)
Product Code
NBW, CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Philosys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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