510(k) · Cleared
ClearedEuroimmun Anti-Sla/LP Elisa (LGG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun US · NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Cleared on Sep 11, 2012 as substantially equivalent to K021482 (Inova Diagnostics, Inc., 2002) after a 406-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 11, 2012
- Review
- 406 days
- Class
- Class II
- Product code
- NIY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021482 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021482 Quanta Lite Sla (Soluble Liver Antigen) ElisaInova Diagnostics, Inc. · 2002
- This deviceK112221 Euroimmun Anti-Sla/LP Elisa (LGG)Euroimmun US · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021482 | Quanta Lite Sla (Soluble Liver Antigen) Elisa | Inova Diagnostics, Inc. | 2002 | — |
| 0 (this device) | K112221 | Euroimmun Anti-Sla/LP Elisa (LGG) | Euroimmun US | 2012 | — |
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 NIY? 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? (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 |
|---|---|---|---|
| * | K021482 | Quanta Lite Sla (Soluble Liver Antigen) ElisaSummary page 2…EUROIMMUN US INC. J. Substantial Equivalence Information: 1. Predicate device name (s): nova Quanta Lite SLA ELISA 2. Predicate 510(k) number(s):. K02 1482 3. Comparison with predicate: Similarities Item New Device… | 2002 |
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 K021482.
How does its category compare?
All NIY devicesNIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NIY
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · NIY
Too few NIY 510(k)s in any year since 2007 to give a median.
Recalls per year · NIY
No recall names NIY since 2007.
Adverse event reports per year · NIY
No MAUDE report names NIY 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 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 | 0 | — | 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-SLAILP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLAILP (soluble liver antigen/liver-pancreas antigen) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 1, in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112221: Euroimmun Anti-Sla/LP Elisa (LGG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112221
Report an extraction error
Are you the manufacturer?
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