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  1. Study conducted in October–November 2009. Data on file, Abbott Diabetes Care Inc. Study results have not been evaluated by the U.S. Food and Drug Administration (FDA). The study concluded that while all three systems met the accuracy standard currently used by FDA (ISO 15197:2003), the accuracy results for the FreeStyle system were statistically significantly higher than the accuracy results for the OneTouch Ultra2 system and the Contour system. Per ISO 15197:2003, all comparisons were made by trained operators using fingertip samples for both test meters and the reference. The FreeStyle Freedom Lite and FreeStyle Lite meters, using GDH-FAD based FreeStyle Lite test strips, were cleared together by the FDA and share performance specifications, including accuracy; these two meters use the same coulometric biosensor technology to measure glucose.
  2. Not affected by maltose, galactose or lactose. Do not use FreeStyle Lite systems or FreeStyle Freedom Lite systems during xylose absorption testing. Data on file, Abbott Diabetes Care Inc. Study conducted in 2011.
  3. Comparison among leading brands (FreeStyle Lite, OneTouch Ultra, Accu-Chek Aviva, Contour). Data on file at Abbott Diabetes Care, Dec 2011; comparison vs. OneTouch Ultra Blue test strip with OneTouch Ultra2 meter.

DOC27703-Rev-B 09/13

ADC-00005 Ver 1.0 06/14

DOC27682-Rev-A 05/12