The Roche Diagnostics ACCU-CHEK Pocket Compass Diabetes Management Software is a single-use accessory system indicated for use with compatible Disetronic insulin pumps and Accu-Chek blood glucose meters to download data to a personal digital assistant (PDA) for analysis and evaluation of diabetes management.
Features and Claims
The device enables users to review, analyze, and evaluate historical blood glucose test results and insulin infusion pump data to support effective diabetes management, including calculating an insulin or carbohydrate dose based on user-entered data.
Classification and Regulation
The device is classified as a class II device, subject to general controls provisions of the Federal Food, Drug, and Cosmetic Act, including requirements for annual registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
The FDA has determined that the device is substantially equivalent to a legally marketed predicate device and has granted clearance for marketing.
Manual:
Download: 510(k) Summary: ACCU-CHEK Pocket Compass Diabetes Management Software
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