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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) using the 1235 AutoDELFIA automatic immunoassay system.

The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) 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 AutoDELFIA® Neonatal 17 α-OH-progesterone L kit. The document declares its substantial equivalence to a predicate device (AutoDELFIA® Neonatal 17 α-OH-progesterone kit, K042425) and discusses the general intended use and description of the device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report proving the device meets those criteria, or the specific performance metrics typically expected in an AI/software device evaluation.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance with the specified details. The document is for a laboratory diagnostic kit, not an AI/software device, and thus the requested information categories (sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or
present in this type of submission.

The document states: "The design control validation of the modified AutoDELFIA Neonatal 17α-OH-progesterone L kit has been done, and the performance of the modified kit is equivalent to the performance of the original AutoDELFIA Neonatal17a-OH-progesterone kit." This implies that the validation focused on demonstrating equivalence to the predicate device rather than establishing new, specific performance acceptance criteria for a novel AI system.

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