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RapidHCG Pregnancy Test is a qualitative test that detects the presence of human Chorionic Gonadotropin (hCG) in human urine specimens. The test is a visual one step, in vitro assay. The test is intended for professional use to help diagnose pregnancy in hospital and clinical lab.

The test is a visual one step, in vitro assay.

The provided document is a 510(k) clearance letter from the FDA for the "RapidHCG Pregnancy Test." This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a product's 510(k) submission or a clinical study report. The letter is an official notification that the device has been found substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results from this document. The document only confirms the device's name ("RapidHCG Pregnancy Test"), its intended use (qualitative detection of hCG in human urine to diagnose pregnancy in hospital and clinical lab settings), its regulatory class (Class II), and its product code (JHI).

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