(54 days)
The results of the ENA screen assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), Poly/Dermato Myositis (PM/DM), Scleroderma and CREST. For in vitro diagnostic use only.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Autostat™II ENA-6 Screen Kit." It primarily discusses the regulatory approval and substantial equivalence to a predicate device. This document does not contain specific acceptance criteria or details of a study demonstrating the device's performance against such criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than the technical performance study details.
§ 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).