(212 days)
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.
Not Found
This looks like a 510(k) clearance letter for an in-vitro diagnostic device, not an AI/ML medical device. As such, the typical acceptance criteria and study designs for AI/ML devices (like sample sizes for test sets, expert ground truth, MRMC studies) are not applicable or found in this type of document.
This document describes the regulatory clearance of the ImmuLisa™ dsDNA Antibody ELISA, an enzyme-linked immunosorbent assay, as an aid in diagnosing systemic lupus erythematosus (SLE).
Therefore, I cannot fulfill the request as the provided text relates to an IVD device and not an AI/ML device, and thus does not contain the information required to answer the prompt.
§ 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).