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One Step hCG Pregnancy Urine Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip, cassette and midstream formats are intended for overthe-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only.

One Step hCG Pregnancy Urine/Serum Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.

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The provided document is a 510(k) clearance letter for the Bioscreen Medical Inc. One Step hCG Pregnancy Urine Test and One Step hCG Pregnancy Urine/Serum Test. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication as requested in the prompt.

Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory approval and indications for use.

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