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InSure® II FIT is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. Fecal immunochemical tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency an onemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Health professionals recommend InSure II for use as part of routine physical examinations and in screening for colorectal cancer or other sources of of our g.i. bleeding.

InSure® II fecal immunochemical test (FIT)

The provided text is a 510(k) premarket notification letter from the FDA to ENTERIX, Inc. for their InSure® II Fecal Immunochemical Test (FIT). It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or details about ground truth establishment for either training or test sets.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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