(152 days)
The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
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The provided text is a letter from the FDA regarding the 510(k) premarket notification for the EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) device. While it states that the device is substantially equivalent to a predicate device and can be marketed, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance study details.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.
The document primarily focuses on regulatory approval and classification, not on the technical details of the validation study.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).