(143 days)
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The provided text is a 510(k) premarket notification letter from the FDA for a device called "PS-UNIT CASSETTE/Serum and Urine Combo HCG Test" (later referred to as "One Step Serum / urine Combo HCG Cassette Test"). It does not contain information about acceptance criteria, device performance, or a study proving its conformance to such criteria. The letter primarily confirms that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 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.