(24 days)
The San Diego Biotech HCG Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. THIS TEST IS INTENDED FOR PROFESSIONAL AND LABORATORY USE ONLY.
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I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an indication for use statement for the San Diego Biotech hCG Pregnancy Test. It does not include information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This information would typically be found in the device's 510(k) premarket notification or associated technical documentation, which is not provided in the input.
§ 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.