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The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. The test system is used to detect in patient serum samples the presence of anti-neutrophil cytoplasm antibodies (ANCA) directed against Myeloperoxidase (MPO) and Serine Proteinase 3 (PR3) ; and anti-glomerular basement membrane (GBM) antibodies.

The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small vessel vasculitis.

Clinical utility:

The presence of anti-MPO and anti-PR3 antibodies associated primary systemic small vessel vasculitis: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopatic crescentic glomerulonephritis; and the presence of anti-GBM antibodies is associated with Goodpasture's syndrome.

FIDIS™ VASCULITIS* kit is used on the FIDIS Analyser, MLX-BOOSTER Software and Washer.

FIDIS™ VASCULITIS* kit could be used with CARIS™ system (diluting and dispensing device).

This test is for in vitro diagnostic use.

• Detection of the serologic markers for primary systemic small vessel vasculitis (ANCA) and for Goodpasture syndrome (GBM)

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings.

The provided document is a 510(k) clearance letter for the FIDIS™ VASCULITIS* device and its "Indications For Use" statement. It does not contain information about acceptance criteria, detailed study results, sample sizes for training or test sets, expert qualifications, or adjudication methods for ground truth establishment.

Based on the nature of the document as an FDA 510(k) clearance, it primarily focuses on the device's substantial equivalence to a legally marketed predicate device rather than comprehensive performance study details. The information required in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically found in the 510(k) summary or the full 510(k) submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information from the given text.

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