(164 days)
One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.
One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.
The provided text describes an FDA 510(k) clearance letter for a device called "One-Step Midstream Style hCG Pregnancy Test." However, it does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a performance study.
The document is a regulatory approval letter and focuses on the substantial equivalence of the device to a legally marketed predicate, allowing it to be marketed. It does not include the technical details of device performance testing.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. To answer your questions, I would need a different document, such as a study report, a technical file, or a summary of safety and effectiveness from the 510(k) submission, which typically contains this kind of information.
§ 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.