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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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dBest hCG Panel Test Kit is a simple one step immunochromatographic assay for rapid, semi-quantitative detection of hCG in urine with cutoffs of 25, 100, 500, 2,000 and 1.0,000 mlU/mL. The dBest hCG Panel Test Kits are for professional, physician's offices laboratory and OTC use, for the early detection of pregnancy.

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This document is a 510(k) clearance letter from the FDA for a device called "dBest hCG Panel Test Kits." It does not contain the detailed information required for a study report on acceptance criteria and device performance. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or study types (MRMC, standalone, etc.) from this document. This document is a regulatory approval, not a scientific study report.

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