(29 days)
CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine, and is indicated for use from four days before the expected missed period.
Not Found
The provided text is a 510(k) premarket notification approval letter for the Clear Blue Easy™ Early Result Pregnancy Test. It acknowledges the device's substantial equivalence to previously marketed predicate devices. However, this document does not contain the details required to answer your specific questions about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.
The letter focuses on regulatory approval based on substantial equivalence and general controls, rather than on a detailed scientific study report.
Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need access to the actual 510(k) submission document (K013372) which would outline the performance data and testing conducted by Unilever United States, Inc.
§ 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.