510(k) · Cleared
ClearedEL-Anca: Anti-Mpo, Anti-PR3, Anti-Mpo and Anti-PR3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratest Laboratories, Inc. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Jul 20, 2006 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 20, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
TheraTest EL- ANCATM: anti-MPO- and EL- ANCATM: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis. TheraTest EL-ANCA…
Read the full statement (142 words)
TheraTest EL- ANCATM: anti-MPO- and EL- ANCATM: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.
TheraTest EL-ANCA TM:anti-MPG is intended for use in clinical laboratories as in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase. Measurement of anti-MPG aids in the diagnosis of microscopic polyangiitis.
TheraTest EL-ANCA TM : anti-PR3 is intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil proteinase 3. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061376: EL-Anca: Anti-Mpo, Anti-PR3, Anti-Mpo and Anti-PR3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061376
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026