Abbott Receives FDA Clearance For New, Easier-to-Use FreeStyle Lite® Test Strips
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Abbott proclaimed that it has standard 510(k) headroom from the U.S. Food and Drug Administration (FDA) for its new FreeStyle Lite bloodline glucose tryout strips. The new FreeStyle Lite examination strips belittle preventive during ancestry glucose examination and are intentional to propose a bettor examination get.
The new FreeStyle Lite tryout strips do not use the GDH-PQQ(1) enzyme, which can be moved by green non-glucose sugars. The new FreeStyle Lite exam strips use a GDH-FAD(2) enzyme which is untouched by usual non-glucose sugars, such as maltose or galactose, and minimizes the voltage for over-the-counter hindrance.(3)
“The new FreeStyle Lite essay strips typify Abbott’s up-to-the-minute achiever in delivering groundbreaking products for citizenry life with diabetes ,” aforesaid Heather L. Mason, older frailty prexy, Abbott Diabetes Care. “By minimizing hindrance and providing a meliorate examination know(4), Abbott is delivering on what patients and wellness charge professionals exact in diabetes charge, specially for multitude who use insulin to care their diabetes.”
The new FreeStyle Lite trial strips are compatible with all FreeStyle Lite bloodline glucose monitoring systems, eliminating the indigence to transposition meters. The FreeStyle Lite strips boast a new, easier-to-use ZipWik* figure tapering essay funnies that offers a meliorate lineage glucose examination see. The new strips are intentional to insure quicker line covering and to slim the act of wrongdoing messages and haggard run strips. The new run strips too offering all the like benefits FreeStyle Lite users get occur to gestate, specifically: no-coding requisite, the earth’s smallest line taste sizing and about unpainful examination.
The low shipments of new FreeStyle Lite trial strips volition embark to U.S. customers in July. Retailers and consumers can look far-flung availableness by the end of August 2010. FDA headway follows Abbott’s late promulgation of European accessibility of the new FreeStyle Lite tryout strips. The new FreeStyle Lite trial strips are usable in 14 European countries. Over the climax months, the new FreeStyle Lite tryout strips volition be uncommitted to customers in Australia, Israel and Norway.
Abbott Diabetes Care, based in Alameda, California, is a leader in development, fabrication and merchandising glucose monitoring systems intentional to assistant mass improve care their diabetes.
Abbott is a planetary, broad-based wellness attention society devoted to the uncovering, growth, construct and selling of pharmaceuticals and checkup products, including nutritionals, devices and nosology. The society employs roughly 83,000 mass and markets its products in more than 130 countries.
(1) Glucose dehydrogenase pyrroloquinoline quinine
(2) Glucose dehydrogenase flavin a dinucleotide
(3) The new FreeStyle make of exam strips is not unnatural by vernacular meddlesome substances, including o, uric battery-acid, empirin and phenaphen (paracetamol).
(4) Versus the master FreeStyle Lite run peel. Study conducted in 2009. Data on charge, Abbott Diabetes Care, Inc.
ZipWik is a brandmark of the Abbott Group of companies in several jurisdictions.
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