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FDA CLEARS TWO GLUCOSE TEST METERS

FDA has cleared for marketing two glucose test meters used with personal digital assistants (PDAs).

The devices will allow people with diabetes to more easily track and manage their blood sugar levels through use of computer technology.

The products are the FreeStyle Tracker Diabetes Management System, made by TheraSense, Inc., of Alameda, Calif., and the Accu-Check Advantage Module, made by Roche Diagnostics Corp., of Indianapolis, Ind.

The products, which have two components with associated software, integrate parts of each company's currently marketed glucose meters and test strips with a Handspring Visor PDA.

To use, the patient inserts a glucose meter module into the hand-held computer. The user then inserts a test strip into the meter, collects a blood sample, and places it onto the test strip. The hand-held computer reads the glucose levels from the measurement module, displays the results, and stores the information in an electronic database. The test results can also be uploaded onto a personal computer.

In addition to measuring and tracking glucose levels, the new systems allow users to track a variety of other data that may affect their health, such as insulin usage, food intake, exercise, and medicine.

The products were cleared under FDA's "Special" 510k review process. This alternative approach is used for faster review of modified versions of already cleared medical devices.

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