(63 days)
The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.
Not Found
The provided text does not contain information about acceptance criteria, device performance, or any studies with AI or human readers. The document is a 510(k) clearance letter from the FDA for a device called "EUROIMMUN ANA IFA: Hep-20-10," which is an indirect fluorescent antibody test for detecting antibodies against cell nuclei.
Therefore, I cannot provide the requested information.
§ 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).