(56 days)
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
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.