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The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The OC Light test is recommended for use in 1) routine physical examinations 2) monitoring for bleeding in patients 3) screening for colorectal cancer or gastrointestinal bleeding

The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces.

The provided text is a 510(k) premarket notification approval letter for "The Polymedco OC Light FOB Test." This document approves the device based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data that would be found in a study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, because this information is not present in the provided text.

The text focuses on the regulatory approval and indications for use, without detailing the underlying performance studies.

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