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dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal cancer. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer

dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood.

The provided text is a 510(k) clearance letter from the FDA for a device called "dBest One Step Occult Blood Test Kit". It confirms the device's substantial equivalence to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies.

The document primarily focuses on regulatory clearance, device name, regulation number, product code, and the general indications for use. It doesn't include the technical performance data that would typically be found in a study report submitted as part of the 510(k) application.

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