(155 days)
The Good Morning Test kit is a qualitative chromatographic immunoassay, which determines whether a woman is pregnant or not by identifying the presence of hCG in urine.
The Good Morning Test kit is a qualitative chromatographic immunoassay
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Standard Diagnostics, Inc. Good Morning Test" for Human Chorionic Gonadotropin (HCG). This document does not contain the detailed study information required to answer the questions about acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's clearance is based on substantial equivalence to an existing device, not necessarily on a new full clinical trial detailed within this document.
Therefore, I cannot provide the requested information from the given text. A 510(k) submission summary or the full submission itself would be needed to extract this level of detail about the device's performance study.
§ 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.