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e.p.t Certainty® 1-Step 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 four days before the expected period.

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This document is a 510(k) premarket notification acceptance letter for the e.p.t Certainty® 1-Step Pregnancy Test. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for testing or training sets.

To get this information, you would typically need to refer to the substantial equivalence documentation submitted by Unipath Ltd. to the FDA, which is not provided in this excerpt.

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