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e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and may be used before the expected period.

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The provided text is related to an FDA 510(k) clearance for the e.p.t. Pregnancy Test. While it details the regulatory aspects and intended use, it does not contain the specific information required to complete the table and answer the study-related questions.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which means specific performance data for the e.p.t. Pregnancy Test, beyond its intended use, is not detailed in this clearance letter. Such data would typically be found in the 510(k) summary or the full submission, which is not provided here.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details from the given text.

The only information that can be gleaned is:

• Device Name: e.p.t.® Pregnancy Test
• Intended Use: Over-the-counter urine hCG test for the detection of pregnancy. Indicated for use from the first day of a missed period and also for detection of pregnancy before the expected period.
• Regulatory Class: Class II
• Product Code: LCX
• Market Type: Over-The-Counter Use

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