(23 days)
The San Diego Biotech HCG Pregnancy Dipstick 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.
Not Found
This document is a 510(k) clearance letter for the San Diego Biotech HCG Pregnancy Dipstick Test and does not contain detailed information about the acceptance criteria and study proving device performance. The letter confirms substantial equivalence to a predicate device but does not include the specifics of the performance study that would show how the device meets acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a different document, such as the 510(k) summary or the actual performance study report submitted by San Diego Biotech.
§ 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.