Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite® Test Strips

-- New FreeStyle Lite® test strips receive 510(k) clearance.

ALAMEDA, Calif., May 24 /PRNewswire-FirstCall/ -- Abbott today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle Lite blood glucose test strips. The new FreeStyle Lite test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.

The new FreeStyle Lite test strips do not use the GDH-PQQ(1) enzyme, which can be affected by common non-glucose sugars. The new FreeStyle Lite 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)

"The new FreeStyle Lite test strips represent Abbott's latest success in delivering innovative products for people living with diabetes," said Heather L. Mason, senior vice president, Abbott Diabetes Care. "By minimizing interference and providing a better testing experience(4), Abbott is delivering on what patients and health care professionals demand in diabetes care, especially for people who use insulin to manage their diabetes."

The new FreeStyle Lite test strips are compatible with all FreeStyle Lite blood glucose monitoring systems, eliminating the need to switch meters. The FreeStyle Lite strips feature a new, easier-to-use ZipWik* design tapered test strip 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 new test strips also offer all the same benefits FreeStyle Lite users have come to expect, specifically: no-coding required, the world's smallest blood sample size and virtually pain-free testing.

The first shipments of new FreeStyle Lite test strips will ship to U.S. customers in July. Retailers and consumers can expect widespread availability by the end of August 2010. FDA clearance follows Abbott's recent announcement of European availability of the new FreeStyle Lite test strips. The new FreeStyle Lite test strips are available in 14 European countries. Over the coming months, the new FreeStyle Lite test strips will be available to customers in Australia, Israel and Norway.

Related Resources and Links

Abbott Diabetes Care: www.abbottdiabetescare.com

FreeStyle: www.myfreestyle.com

Abbott: www.abbott.com



About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at www.abbottdiabetescare.com.  

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.  The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's  Web site at www.abbott.com.

(1) Glucose dehydrogenase pyrroloquinoline quinine

(2) Glucose dehydrogenase flavin adenine dinucleotide

(3) The new FreeStyle brand of test strips is not affected by common interfering substances, including oxygen, uric acid, aspirin and acetaminophen (paracetamol).

(4) Versus the original FreeStyle Lite test strip. Study conducted in 2009. Data on file, Abbott Diabetes Care, Inc.

* ZipWik is a trademark of the Abbott Group of companies in various jurisdictions.



SOURCE Abbott

Suggested Articles

The eight-year deal will initially cover lupus drug Benlysta and could expand to other GSK specialty-care products in the future.

Amarin had big plans for Vascepa after a big label expansion last year, but it lost a patent fight—and now a generic has won FDA approval.

Intercept Pharmaceuticals, eager to market its potential nonalcoholic steatohepatitis medicine obeticholic acid, will have to keep waiting.