(28 days)
The Clearblue® Early Detection Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Clearblue® Early Detection Pregnancy Test. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about the acceptance criteria or the study data that proves the device meets those criteria. This type of information is typically found in the 510(k) submission itself, not in the public-facing clearance letter.
Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's clearance and its intended use, but it does not detail the technical performance studies.
To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would typically include performance data, study designs, sample sizes, and ground truth establishment methods.
§ 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.