Search Results

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.

Not Found

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.

Ask a specific question about this device

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.

Not Found

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

Ask a specific question about this device