510(k) · Cleared
ClearedModification to Fidis Vasculitis, Model MX007
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 Dec 21, 2007 as substantially equivalent to K053012 (Biomedical Diagnostics (Bmd) SA, 2006) after a 308-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Dec 21, 2007
- Review
- 308 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053012 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK053012 Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 2006
- This deviceK070458 Modification to Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 2007
- Descendant · cites it directly · 0 of its ownK100917 Fidis Vasculitis Assay Kit and Analyzer and Caris SystemBiomedical Diagnostics (Bmd) SA · 2010
Most influential descendants
Showing 1 of 1 · See all- K100917Fidis Vasculitis Assay Kit and Analyzer and Caris SystemBiomedical Diagnostics (Bmd) SA · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053012 | Fidis Vasculitis, Model MX007 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| 0 (this device) | K070458 | Modification to Fidis Vasculitis, Model MX007 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| +1 | K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris System | Biomedical Diagnostics (Bmd) SA | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 |
|---|---|---|---|
| * | K053012 | Fidis Vasculitis, Model MX007Summary page 3…expressed in arbitrary units per mL (AU/mL). 5) Predicate Device 510K Number Device Classification Name Manufacturer Name K053012 FIDISTM VASCULITIS Biomedical Diagnostics… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris System | 2010 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K100917 (Biomedical Diagnostics (Bmd) SA, 2010) has gone furthest, with 0 descendants of its own.
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. 2007, 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 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…
Read the full statement (184 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070458: Modification to Fidis Vasculitis, Model MX007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070458
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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