Abbott's new FreeStyle test strips receive FDA clearance

Following the recent clearance of its FreeStyle Lite® blood glucose test strips, Abbott (NYSE: ABT) today announced that it has also received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips. The new FreeStyle test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.

In a similar fashion to the FreeStyle Lite blood glucose test strips, the new FreeStyle test strips do not use the GDH-PQQ(1) enzyme, which can be affected by common non-glucose sugars. The new FreeStyle test strips use a GDH-FAD(2) enzyme which is unaffected by common non-glucose sugars, such as maltose or galactose, and minimizes the potential for other interference.(3)

"Abbott's new FreeStyle test strips offer innovative technology that delivers on what patients and health care professionals demand in diabetes care," said Heather L. Mason, senior vice president, Abbott Diabetes Care. "The innovative technology minimizes interference and is designed to make the new FreeStyle test strips easier to use."

The new FreeStyle test strips are compatible with all FreeStyle blood glucose monitoring systems, eliminating the need to switch meters. The FreeStyle strips feature a new, easier-to-use tapered design with ZipWik* tabs that offers a better blood glucose testing experience. The new strips are designed to ensure faster blood application and to reduce the number of error messages and wasted test strips.

The first shipments of new FreeStyle test strips will be sent to U.S. customers in August. Retailers and consumers can expect widespread availability by the end of October 2010. With FDA clearance of the new FreeStyle test strips, new FreeStyle and FreeStyle Lite test strips will now be available in the U.S. and 15 European countries. Over the coming months, the new FreeStyle and FreeStyle Lite test strips will be available to customers in Australia, Israel and Norway.