(63 days)
An enzyme linked immunosorbant assay (ELISA) for the semiquantitative detection of ribosome antibody in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment. This document only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot provide the requested information from the given 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).