510(k) · Cleared
ClearedEuroimmun Anti BP 180-4X Elisa (Igg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun Us, Inc. · OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Cleared on Mar 16, 2009 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 16, 2009
- Review
- 98 days
- Class
- Class II
- Product code
- OEG
- 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 OEG? 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?
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 OEG devicesOEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OEG
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OEG
Too few OEG 510(k)s in any year since 2007 to give a median.
Recalls per year · OEG
No recall names OEG since 2007.
Adverse event reports per year · OEG
No MAUDE report names OEG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EUROIMMUN Anti-BP 180-4X ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against BP 180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083615: Euroimmun Anti BP 180-4X Elisa (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083615
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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