(38 days)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of ScI-70 antibodies in human serum as an aid in diagnosis of systemic sclerosis / scleroderma in conjunction with other laboratory and clinical findings.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the ImmuLisa Scl-70 Antibody ELISA, which indicates the device has been reviewed and found substantially equivalent to legally marketed predicate devices. However, it does not include details about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment for performance studies.
§ 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).