# K053012: Fidis Vasculitis, Model MX007

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Mar 2, 2006 after 127 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070458: Modification to Fidis Vasculitis, Model MX007 (2007), 1 descendant of its own
- K100917: Fidis Vasculitis Assay Kit and Analyzer and Caris System (2010), 0 descendants of its own

## Indications for use
The FIDISTM VASCULITIS* kit is a seni-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometty 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-glornenilar basement membrane ((iBM) antibodies. 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 vessel vasculitis. Clinicalutility: The presence of anti-MPO and anti-PR3 antibodies associated primary systemic small vessel vasculitis: Wegener's granulomatosis, Churg Strauss syndromes, microscopic :eriarteritis and idiopatic crescentic glomerulonephritis; and the presence of anti-GBM antibodies is associated with Goodpasture's syndrome. FIDIS TM VASCULITIS* kit is used on the FIDIS Analyser, MLX-BOOSTER Software and Washer. FIDISTM VASCULITIS* kit could be used with CARISTM 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)

Source page: https://510kreport.com/device/K053012
Methodology: https://510kreport.com/methodology