# K100917: Fidis Vasculitis Assay Kit and Analyzer and Caris System

- Pathway: 510(k) (Special)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Nov 3, 2010 after 215 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K053012 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070458: Modification to Fidis Vasculitis, Model MX007, Biomedical Diagnostics (Bmd) SA (2007) Summary page 5.

## Indications for use
The IPIDISTM VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidlase (MPQ), Serine Proteinase 3 (PR3) and antibodies directed against glornerular basement membrane (OSM) in human serum samples. The results of the FIDISTM 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 blood vessel vaseulitides and glomnerular basement membrane disease. Clinical utility: The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomnatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome. FIDISTM VASCULITIS* kit uses serum only, and is to be run on the FIDIS' Instrument and MLX-BOOSTER Software. FIDISTM VASCULITIS* kit may be used wit the CARISTM system (diluting and dispensing device). This kit is for In vitro Diagnostic Use. * Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Ooodpasture syndrome (GBM).

Source page: https://510kreport.com/device/K100917
Methodology: https://510kreport.com/methodology