510(k) · Cleared
ClearedFidis Vasculitis Assay Kit and Analyzer and Caris System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Diagnostics (Bmd) SA · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Nov 3, 2010 as substantially equivalent to K070458 (Biomedical Diagnostics (Bmd) SA, 2007) after a 215-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Nov 3, 2010
- Review
- 215 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053012 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK053012 Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 2006
- 1 generation backK070458 Modification to Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 2007
- This deviceK100917 Fidis Vasculitis Assay Kit and Analyzer and Caris SystemBiomedical Diagnostics (Bmd) SA · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053012 | Fidis Vasculitis, Model MX007 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| −1 | K070458 | Modification to Fidis Vasculitis, Model MX007 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| 0 (this device) | K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris System | Biomedical Diagnostics (Bmd) SA | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOB device
- #1 K261466 Alegria Flash MPO; Alegria Flash PR3; Alegria…score 11.9 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070458 | Modification to Fidis Vasculitis, Model MX007Summary page 5…cal characteristics The following table summarizes similarities and differences between the modified FIDISTM VASCULITIS and the predicate device FIDISTM VASCULITIS (K070458). _________________ Comparison with the predicate Predicate… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MOB devicesMOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MOB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOB
221in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOB
1in 2012
MAUDE reports naming product code MOB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 379 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 221 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (185 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100917: Fidis Vasculitis Assay Kit and Analyzer and Caris System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100917
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026