Abbott Laboratories, MediSense Products Receives FDA Clearance for New Blood Glucose Monitoring Test Strip

25-Jun-2001

Abbott Laboratories, MediSense Products announced today that it has received U.S. food and Drug Administration marketing clearance for its newest test strip for blood glucose monitoring, utilizing MediSense's newly developed TrueMeasure™ technology. The new strips, which represent fifth-generation test strip technology, incorporate several advanced features and benefits designed to enhance the accuracy of test results for people with diabetes.

"This strip builds upon our company's history of developing innovative products that increase accuracy of testing and ease of use for people with diabetes," said Mike Collins, vice president and general manager, MediSense Products. "As leaders in the evolution of biosensor test-strip development, we are excited about the spectrum of new benefits that TrueMeasure technology offers."

Abbott Laboratories, MediSense Products incorporates a three-electrode design into its new strip, which is specifically designed to act as a trigger, starting the glucose test only after a sufficient blood sample is applied to the strip, thereby providing more accurate results.

The new test strip requires a very small blood sample to provide a result within 20 seconds. It also utilizes a proprietary new test chemistry that minimizes false low and high readings caused by interfering substances. The new chemistry is more specific for identifying glucose and, during testing, displayed no interference from more than 60 common medications and over-the-counter products including vitamin C and acetaminophen. This new chemistry combination is used only in MediSense test strips with TrueMeasure technology.

In addition to the three-electrode design and new test chemistry, the test strip can be used as either an end-fill or top-fill strip, a feature that makes applying the blood sample simpler and more convenient. People using these test strips have the option of applying blood samples to both the end and top of the test strips, whichever is more comfortable for them.

The strips also incorporate a semi-opaque cover for visual confirmation that a blood sample has filled the test chamber. The cover allows testers to quickly see if a second drop of blood needs to be added to conduct the test. Additional blood can be added within 30 seconds if necessary, thereby reducing strip waste.

The new strip utilizing TrueMeasure technology is compatible with Abbott Laboratories, MediSense Products' existing Precisions Xtra™ /MediSense® Optium™ meters and will be used by future meters introduced by the company. The strips will be available in 50 and 100 count packages at most major pharmacy chains beginning in July 2001.

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