(315 days)
One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the counter (OTC) use and use in clinical laboratories.
One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for in vitro diagnostic professional use in clinical laboratories only.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a human chorionic gonadotropin (HCG) pregnancy test. It does not contain information about acceptance criteria, device performance, or details of a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
Therefore, I cannot provide the requested information based on the given text.
The text only states that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It defines the device's intended use and formats.
§ 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.