(60 days)
CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-thecounter qualitative urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.
Not Found
The provided text is a 510(k) summary for the CLEARBLUE EASY DIGITAL PREGNANCY TEST. It primarily covers the regulatory determination of substantial equivalence and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the format requested.
Therefore, I cannot extract the information to fulfill your request. The document is a regulatory letter indicating clearance, not a scientific study report.
§ 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.