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510(k) Data Aggregation
K Number
K073699Device Name
MCT-DIABETES
Manufacturer
MYCARE TEAM, INC.
Date Cleared
2008-03-26
(86 days)
Product Code
NBW, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
MYCARE TEAM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MCT-Diabetes™ software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT Diabetes is designed for home use and professional healthcare settings.
Device Description
MCT-Diabetes software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT-Diabetes is designed for home use and professional healthcare scttings. It is an accessory device to most manufactured models homc-use blood glucose monitors, including glucose monitoring devices by Roche Diagnostics, Bayer, BD, Johnson & Johnson, Abbott, and Nova Biomedical. The list of supported devices is located at www.mycareteam.com.
The purpose of the electronic diabetes management system is to help the user manage their own blood sugar information to better regulate diabetes treatments and control blood glucose. The MCT-Diabetes system holds a convenience function, as the user can upload blood glucose data from a variety of currently marketed blood glucose monitors into one location for viewing.
Finally, after the user transmits and stores blood glucose data to the secure database, the MCT-Diabetes system allows family members and/or hcalthcare professionals who have permission from the primary user and a password to view and monitor the user's data and reports. Four different types of chart displays are available, and the user selects the time period and the type of output. The subject can view their blood glucose information over time and can compare to previous time periods, to help the subject better manage their disease over time. The subject can also enter and track other health-rclated information such as body weight, blood pressure, and level of exercise.
The MCT-Diabetes device is an Internet-based software device that has physical requirements common to most home personal computers users (Pentium 4 microprocessor or greater, 256Mb of RAM memory, 10Gb secondary storage, Microsoft Internet Explorer v6.0 or later, etc.). The MCT-Diabetes device is a sccure device and meets or exceeds HIPAA Guidelines for data and patient security.
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