(164 days)
Pure-Aid Pregnancy Test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human urine. The test is for Over-The-Counter use. The test is for the early detection of pregnancy.
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The provided text is a 510(k) clearance letter from the FDA for the "Pure-Aid Pregnancy Test." This document does not contain the specific details required to answer your questions about acceptance criteria and the study that proves the device meets them.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... "
This means the device was cleared based on its substantial equivalence to an existing, legally marketed device (the "predicate device"), rather than a new clinical study demonstrating specific performance metrics against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need to access the actual 510(k) submission document (K053452) which would contain the performance data and the comparison to the predicate device.
§ 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.