(234 days)
The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a family of Pregnancy One Step Rapid Tests (Strip, Cassette, Midstream). It states that the FDA has reviewed the premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices.
However, this document does not contain the acceptance criteria, details of the study, reported device performance, sample sizes, ground truth establishment, or expert qualifications that would be found in a detailed study report. The FDA clearance letter primarily confirms the device's substantial equivalence to existing devices based on the information submitted by the manufacturer. It does not typically include the raw performance data or a detailed breakdown of the studies conducted by the manufacturer.
Therefore, I cannot extract the requested information from the provided text. The document confirms the FDA's regulatory clearance but does not present the underlying study data and acceptance criteria in the format requested.
§ 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.