(242 days)
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE
The provided text describes a 510(k) summary for the "DAVID PREGNANCY TEST (STRIP AND MIDSTREAM)". However, it does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.
The document primarily focuses on:
- Contact details for the submitter and manufacturer.
- Device name, classification, and intended use.
- FDA's letter confirming substantial equivalence to a predicate device.
- Indications for Use.
Therefore, I cannot fulfill the request to describe acceptance criteria, device performance, or study details, as this information is not present in the provided text.
§ 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.