Abbott Submits Marketing Notification for U.S. FDA Clearance of New FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips

Abbott Submits Marketing Notification for U.S. FDA Clearance of New FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips
Strips Use New Chemistry Designed to Minimize Interference From Non-Glucose Sugars

Alameda, Calif., August 28, 2009 - Abbott today announced that it has submitted 510(k) applications to the United States Food and Drug Administration (FDA) for clearance of its new FreeStyle® and FreeStyle Lite® blood glucose test strips. The new test strips use the glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD) enzyme which, if cleared by the FDA, will enhance the FreeStyle brand of blood glucose test strips by minimizing the potential interference from common non-glucose sugars.

The new FreeStyle and FreeStyle Lite test strips will be compatible with all FreeStyle brand glucose monitoring systems so there is no need for providers or patients to switch from their current FreeStyle brand meters. Consumers can continue to use the same FreeStyle or FreeStyle Lite test strips that they have been using with their current FreeStyle brand meters. Upon FDA clearance, Abbott will introduce the new test strips into the market.

Abbott intends to file additional applications for the new FreeStyle and FreeStyle Lite brand of test strips by the end of this year in Europe and Canada.

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 more than 72,000 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.

 

 

DOC20257-Rev-A 08/09