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510(k) Data Aggregation
K Number
K193340Device Name
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
Manufacturer
Date Cleared
2020-09-11
(284 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
MicroTech Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GoChek Blood Glucose Monitoring System
The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Connect Blood Glucose Monitoring System
The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
Device Description
GoChek Blood Glucose Monitoring System and GoChek Connect Blood Glucose Monitoring System (also called "GoCheck series") perform quantitative assays of glucose in fresh capillary whole blood obtained from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
Both the systems share the same GoChek Blood Glucose test strips. It has a reagent system in test window that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample. This reaction, in turn produces an electrical current that is measured by the meter's electronics through test strip contact area. The meter, then calculates and displays the blood glucose concentration reading, calibrated to a plasma reference.
GoChek Connect Blood Glucose Monitoring System has Bluetooth and serial interfaces that comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. This Bluetooth function will allow user to transfer their test results from BG meter to a specific app which developed by MicroTech. Users can choose to utilize these function by following the instruction to set it up, otherwise these functions will remain shut off.
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