(23 days)
CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of preguancy. The test has a sensitivity of 50mIU/ml hCG in urine, and is indicated for use from four days before the first day of the missed period.
Not Found
This document is a 510(k) clearance letter from the FDA for a pregnancy test, not a study describing acceptance criteria or performance data for an AI/ML device. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device and states the indications for use, but does not contain performance study details typically associated with AI/ML device evaluations.
§ 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.