(396 days)
QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.
The device consists of a plastic housing and test stick containing an immunochromatographic strip. The test pad contain colloidal gold conjugate with mouse monoclonal antibodies against beta subunit of hCG and test strip contain mouse monoclonal antibody against alpha subunit of hCG ( test line )and goat antimouse polyclonal antibodies ( Control line ). The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine, in some cases as early as 3 days before the expected period.
The provided text is a 510(k) summary for the "QuikResponse™ One Step Midstream Early Pregnancy Test." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or information about ground truth establishment, expert qualifications, sample sizes for test/training sets, or MRMC studies that would be needed to fully answer your request.
The text only states that "The information provided in this pre-market notification demonstrates that QuikResponse™ One Step Midstream Early Pregnancy Test device is substantially equivalent to Firstresponse Pregnancy Test. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supports substantial equivalence to the predicate device."
This statement implies that analytical and possibly clinical studies were conducted and presented to the FDA to demonstrate this equivalence, but the specifics of those studies (acceptance criteria, performance data, methodology, ground truth, etc.) are not included in this public 510(k) summary document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, data provenance, expert information, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.
To obtain that information, one would typically need to review the full 510(k) submission, which is not publicly available in this summarized format. The FDA's letter simply acknowledges the substantial equivalence determination based on the submitted information, without detailing the entire submission's contents.
§ 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.