(22 days)
This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH).
The DELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum into solution, where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the quantity of 17-OHP in the sample.
The provided text is a 510(k) summary for the DELFIA® Neonatal 17α-OH-progesterone kit. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance or information about the study design elements you asked for. The document states:
"The performance of the modified DELFIA Neonatal 17α-OH-progesterone kit was tested both by carrying out in-house studies and by studies in neonatal screening laboratories. The performance of the modified kit was found to be equivalent with the predicate DELFIA Neonatal 17α-OH-progesterone kit and suitable for its intended use."
This statement confirms that studies were done and the device met performance expectations by showing equivalence to a predicate device, but it lacks the quantitative details required to populate your requested table and answer your specific questions about the study methodology.
Without further information from the detailed submission to the FDA, I cannot provide the specifics you're looking for.
§ 862.1395 17-Hydroxyprogesterone test system.
(a)
Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.