(238 days)
The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings. It is designed for the simultaneous detection of 8 autoantibody specificities: double stranded DNA (dsDNA), SSA 60 kDa, SSA 52 kDa, SSB, Sm, Sm/RNP, Sc170 and Jo-1 (*antibodies to dsDNA, Sm, Sm/RNP, SS-A, SS-B, Scl-70 and Jo-1 can be reported using this assay).
Clinical utility:
The test system is used to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases, systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, polymyositis in conjunction with clinical findings and other laboratory tests.
The FIDISTN CONNECTIVE 8* kit is a semi-quantitative homogencous fluorescentbased microparticles immunoassay using flow cytometery readings.
The provided text is a 510(k) summary for the FIDIS™ Connective 8 device, which is an immunoassay for the detection of autoantibodies associated with connective tissue diseases. It does not contain a study detailing the device's performance against acceptance criteria in the way an AI/ML device submission would. This document is a regulatory clearance letter and the "Indications For Use" statement.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document. The document describes the device, its intended use, and the FDA's determination of substantial equivalence to predicate devices, but not a detailed study report of its performance metrics.
§ 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).