(50 days)
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The SSA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies SSA.
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The provided text is a 510(k) premarket notification letter from the FDA for a device called "Aptus (Automated) Application for the SSA ELISA Test System." This document primarily discusses the regulatory approval of the device and its intended use, rather than detailing a specific study and its acceptance criteria as requested.
Therefore, I cannot extract the information about acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs (MRMC, standalone) from the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on presenting a detailed clinical or performance study report.
The "Indications for Use" section (page 2, document 2) describes what the device is intended to do: "The SSA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies SSA." However, it does not specify performance metrics or acceptance criteria for this intended use.
§ 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).