510(k) · Cleared
ClearedVarelisa Mpo Anca, Model 17648/17696
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sweden Diagnostics (Germany) GmbH · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Jun 16, 2004 after a 55-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 16, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041040 Varelisa Mpo Anca, Model 17648/17696Sweden Diagnostics (Germany) GmbH · 2004
- Descendant · cites it directly · 0 of its ownK072358 Bioplex Vasculitis KitBio-Rad Laboratories · 2007
Most influential descendants
Showing 1 of 1 · See all- K072358Bioplex Vasculitis KitBio-Rad Laboratories · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041040 | Varelisa Mpo Anca, Model 17648/17696 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| +1 | K072358 | Bioplex Vasculitis Kit | Bio-Rad Laboratories | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | — | INOVA QUANTA Lite MPO Named without a submission number |
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 |
|---|---|---|---|
| K072358 | Bioplex Vasculitis Kit | 2007 | 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?
- Of its descendants, K072358 (Bio-Rad Laboratories, 2007) 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.
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 Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and qualitative determination of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain autoimlune vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041040: Varelisa Mpo Anca, Model 17648/17696.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041040
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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