510(k) · Cleared
ClearedEuroimmun Anti-LKM-1 Elisa (LGG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun US · NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Cleared on Sep 11, 2012 as substantially equivalent to K000535 (Inova Diagnostics, Inc., 2000) after a 406-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Sep 11, 2012
- Review
- 406 days
- Class
- Class II
- Product code
- NBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000535 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000535 Quanta Lite LKM-1 ElisaInova Diagnostics, Inc. · 2000
- This deviceK112223 Euroimmun Anti-LKM-1 Elisa (LGG)Euroimmun US · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000535 | Quanta Lite LKM-1 Elisa | Inova Diagnostics, Inc. | 2000 | — |
| 0 (this device) | K112223 | Euroimmun Anti-LKM-1 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 NBS? 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 |
|---|---|---|---|
| * | K000535 | Quanta Lite LKM-1 ElisaSummary page 2…333X J. Substantial Equivalence Information. 1. Predicate device name (s): [nova Quanta Lite LKMV-1 ELISA 2. Predicate 510(k) number(s): K000535 3. Comparison with Predicate: Similarities Item New Device… | 2000 |
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.
- 2 other devices also cite its predicate K000535.
How does its category compare?
All NBS devicesNBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NBS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NBS
Too few NBS 510(k)s in any year since 2007 to give a median.
Recalls per year · NBS
No recall names NBS since 2007.
Adverse event reports per year · NBS
No MAUDE report names NBS 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 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-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 1106 of liver-kidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112223: Euroimmun Anti-LKM-1 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/K112223
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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