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Home » FDA: Result Confirmation Needed to Support H. Pylori IVD 510(k)
FDA: Result Confirmation Needed to Support H. Pylori IVD 510(k)
October 1, 2010
In vitro diagnostic (IVD) manufacturers submitting 510(k) applications for devices to detect Helicobacter pylori (H. pylori) should use endoscopic diagnostic tests to confirm and exclude the diagnosis of the bacterial infection, a new FDA draft guidance says.