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Atossa Genetics Inc Receives Warning Letter From Food And Drug Administration


Monday, 25 Feb 2013 08:30am EST 

Atossa Genetics Inc announced that it received a Warning Letter (Letter) from the FDA on February 21, 2013, regarding Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System Collection Test (together, the System). The Letter arises from certain FDA findings during a July 2012 inspection, to which the Company responded in August 2012, explaining why the Company believed it was in compliance with applicable regulations and/or was implementing changes responsive to the findings of the FDA inspection. The FDA alleges in the Letter that following 510(k) clearance the Company changed the System in a manner that requires submission of an additional 510(k) notification to the FDA. Specifically, the FDA observes that the Instructions For Use (IFU) in the original 510(k) submission stated that the user must Wash the collection membrane with fixative solution into the collection vial and the current IFU states apply one spray of Saccomanno's Fixative to the collection membrane and that this change fixes the NAF specimen to the filter paper rather than washing it into a collection vial. At the time that the changes were made the Company determined that a new 510(k) was not required in accordance with the FDA`s guidance document entitled Deciding When to Submit a 510(k) for a Change to an Existing Device. 

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