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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 onwards.

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This document is a 510(k) premarket notification approval letter for the e.p.t.® Pregnancy Test. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the letter itself does not contain the acceptance criteria or the study details that prove the device meets those criteria.

To answer your request, one would typically need to refer to the original 510(k) submission document (K040329) or related technical documentation, which is not provided in the given text. The provided text only states the "Indications for Use" and the FDA's concurrence with the marketing of the device.

Therefore, I cannot provide the requested information based solely on the text provided. The acceptance criteria, study details, sample sizes, expert qualifications, etc., would be found in the detailed submission to the FDA, not in the summary approval letter.

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