(154 days)
Proof Positive Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the qualitative determination of human chorionic gonadotropin (hCG) in urine. The test will be marketed for the retail or "over-the-counter" (OTC) market use.
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The provided text is a 510(k) premarket notification approval letter for the "Proof Positive Electronic Pregnancy Test." While it states the device has been found substantially equivalent to a predicate device and provides its intended use, it does not contain specific information about acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment that would allow a comprehensive answer to your request. The letter is a regulatory approval, not a scientific study report.
Therefore, I cannot extract the requested information from the provided text.
§ 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.