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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.

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