(54 days)
The Texas FIRST SIGH test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.
Not Found
The provided document is a 510(k) premarket notification letter for a device called "FIRST SIGN II." This letter approves the device for marketing and mentions its intended use. However, it does not contain a study report or detailed performance data to describe specific acceptance criteria and how a study proved the device meets them.
The document only states the "Indications For Use" for the FIRST SIGN test: "a 3 minute one step pregnancy test for the detection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use."
Without a detailed study report, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the 510(k) submission itself, which is not provided here.
§ 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.