(28 days)
DavidStrip hCG is a qualitative, two site sandwich immunoassay test kit for the rapid determination of hCG concentration in urine for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for professional use only.
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This document is a 510(k) clearance letter from the FDA for a device called "DavidStrip hCG." It does not contain a study that describes acceptance criteria and device performance. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in the 510(k) submission itself, which is not provided in this 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.