510(k) · Cleared
ClearedEuroimmun Anti-Ena Pool Elisa (Igg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun US · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Apr 9, 2013 as substantially equivalent to K081104 (Aesku Diagnostics, 2008) after a 550-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Apr 9, 2013
- Review
- 550 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081104 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK081104 Aeskulisa Ana Hep-2, Ref 30-7115USAesku Diagnostics · 2008
- This deviceK112996 Euroimmun Anti-Ena Pool Elisa (Igg)Euroimmun US · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081104 | Aeskulisa Ana Hep-2, Ref 30-7115US | Aesku Diagnostics | 2008 | — |
| 0 (this device) | K112996 | Euroimmun Anti-Ena Pool Elisa (Igg) | Euroimmun US | 2013 | — |
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 LLL? 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 LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K081104 | Aeskulisa Ana Hep-2, Ref 30-7115USSummary page 2…N US INC.I J. Substantial Equivalence Information: 1. Predicate device name (s): Aesku Aeskulisa ANA Hep-2 2. Predicate 510(k) number(s): KO081104 3. Comparison with predicate: Similarities Item New Device… | 2008 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K081104.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EUROIMMUN Anti-ENA Pool ELISA (lgG) is intended for the qualitative determination of IgG class antibodies against nuclear antigens (mixture of nRNAISm, Sm, SS-A (SS-A 60/Ro-52), 55-B, Scl-70, and ribosomal P proteins) in human serum. It is used as an aid in the diagnosis of mixed connective tissue disease (MCTD), systemic lupus erythematosus, Sj~gren's syndrome and progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.
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/K112996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112996: Euroimmun Anti-Ena Pool Elisa (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112996
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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