510(k) · Cleared
ClearedAlegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Aug 21, 2026 as substantially equivalent to K040111 (Zeus Scientific, Inc., 2004) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 21, 2026
- Review
- 109 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040111 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK040111 Zeus Scientific, Inc., Athena Multi-Lyte Mpo/PR3 Igg Test SystemZeus Scientific, Inc. · 2004
- This deviceK261466 Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus Scientific · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040111 | Zeus Scientific, Inc., Athena Multi-Lyte Mpo/PR3 Igg Test System | Zeus Scientific, Inc. | 2004 | — |
| 0 (this device) | K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | 2026 | — |
Other ancestors 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040111 | Zeus Scientific, Inc., Athena Multi-Lyte Mpo/PR3 Igg Test SystemSummary page 5…EVICE MEASURES ANTIBODY TO GBM | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K040111, KO71219 ZEUS AtheNA Multi-Lyte Autoimmune Vasculitis Plus Test MOB System (Product Code: A96101) Device Description Summary 21 C… | 2004 |
| * | K071219 | Athena Multi-Lyte GBM Test System | 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?
- 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. 2026, 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?
Alegria FLASH MPO: The Alegria Flash MPO kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to MPO in human serum. It is intended for use as an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument. Alegria FLASH PR3: The Alegria Flash PR3 kit uses chemiluminescent immunoassay…
Read the full statement (174 words)
Alegria FLASH MPO:
The Alegria Flash MPO kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to MPO in human serum. It is intended for use as an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
Alegria FLASH PR3:
The Alegria Flash PR3 kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to PR3 in human serum. It is intended for use as an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
Alegria FLASH GBM:
The Alegria Flash GBM kit uses chemiluminescent immunoassay (CLIA) technology for the semi-quantitative measurement of IgG antibodies to GBM in human serum. It is intended for use as an aid in the diagnosis of Goodpasture’s Syndrome in conjunction with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
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/K261466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261466: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261466
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026