(48 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 Jo-1 ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Jo-1.
Aptus (Automated) Application for the Jo-1 Test System
This document is a 510(k) clearance letter from the FDA for the "Aptus (Automated) Application for the Jo-1 Test System". It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a scientific study report.
§ 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).