510(k) · Cleared
ClearedEuroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)
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 Apr 12, 2013 as substantially equivalent to K052262 (Inova Diagnostics, Inc., 2005) and 4 other predicates after a 508-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 12, 2013
- Review
- 508 days
- Class
- Class II
- Product code
- NIY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K000535 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000535 Quanta Lite LKM-1 ElisaInova Diagnostics, Inc. · 2000
- This deviceK113439 Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013
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) | K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | Euroimmun US | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
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? (5)
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 |
|---|---|---|---|
| * | K052262 | Quanta Lite M2 EP (MIT3) ElisaSummary page 2…510(k) number Disease 8BAg (lgG) Antigens M2 / M2-3E (BPO) Quanta Lite M2 EP (MIT3) ELISA K052262 SpQoo Quanta Lite SplOO ELISA K050662… | 2005 |
| * | K050662 | Quanta Lite SP100 ElisaSummary page 2…Quanta Lite M2 EP (MIT3) ELISA K052262 SpQoo Quanta Lite SplOO ELISA K050662 PMAL Quanta Lite SplOO ELISA* K050662… | 2005 |
| * | K040885 | Quanta Lite GP210 ElisaSummary page 2…Quanta Lite SplOO ELISA* K050662 gp2lO Quanta Lite gp2lO ELISA K040885 LKM-1 Quanta Lite LKM-1 ELISA K000535… | 2004 |
| * | K000535 | Quanta Lite LKM-1 ElisaSummary page 2…Quanta Lite gp2lO ELISA K040885 LKM-1 Quanta Lite LKM-1 ELISA K000535 LC-11 Quanta Lite LKM-1 ELISA t K000535… | 2000 |
| * | K021482 | Quanta Lite Sla (Soluble Liver Antigen) ElisaSummary page 2…Quanta Lite LKM-1 ELISA t K000535 SLA/LP Quanta Lite SLA ELISA K021482 As no FDA cleared test systems were available for two of the 8 antigens the Inova SpIOO ELISA was used as the pr… | 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?
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K052262.
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. 2013, 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 EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgO) Kit is an immune line-blot strip test intended for the qualitative detection of LgG class antibodies against 8 different antigens: AMA-M2, M2-3E (BPO), SplOO, PML, gp2lO, LKM-1, LC-1 and SLAILP in human serum and plasma (EDTA, Li-heparin, Citrate). Detection of these antibodies is used as an aid in the diagnosis of autoimmune liver diseases in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113439: Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113439
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