(56 days)
The TheraTest EL-ANA Profiles: EL-ENA/4 is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA and SSB. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.
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This document is an FDA 510(k) clearance letter for the TheraTest EL-ANA Profiles: EL-ENA/4 device. It declares the device substantially equivalent to legally marketed predicate devices. Unfortunately, the document does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.
This letter is a regulatory approval, not a scientific publication detailing the performance study. To find the information requested, one would typically need to consult the original 510(k) submission document or related technical reports, which are not provided here.
Therefore, I cannot fulfill your request for the table of acceptance criteria and the detailed study information based on the provided text.
§ 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).