# K070458: Modification to Fidis Vasculitis, Model MX007

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Dec 21, 2007 after 308 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: 1 generation back to K053012 (2006). 1 ancestor in all.
1 later device descends 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)
- K053012: Fidis Vasculitis, Model MX007, Biomedical Diagnostics (Bmd) SA (2006) Summary page 3.

## Most influential descendants
- K100917: Fidis Vasculitis Assay Kit and Analyzer and Caris System (2010), 0 descendants of its own

## Indications for use
The FIDIS™ 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 Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples. 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 blood vessel vasculitides and glomerular basement membrane disease. Clinicalutility: The detection of ANCA is associated with primary systemic small blood vessel vasculitides: Wegener's granulomatosis, Churg Strauss syndromes, microscopic periarteritis and idiopathic crescentic glomerulonephritis; and the detection of anti-GBM antibodies is associated with Goodpasture's syndrome. FIDIS™ VASCULITIS* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER Software. FIDIS™ VASCULITIS* kit may be used with the CARIS™ system (diluting and dispensing device). This test is for In vitro Diagnostic Use. * Detection of the serologic markers for primary systemic small blood vessel vasculitides (ANCA) and for Goodpasture syndrome (GBM).

Source page: https://510kreport.com/device/K070458
Methodology: https://510kreport.com/methodology