510(k) · Cleared
ClearedEuroimmun Euroline Ena Profile 9AG (Igg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun US · LKO Anti-Rnp Antibody, Antigen And Control
Cleared on Dec 9, 2014 as substantially equivalent to K123261 (Euroimmun US, 2013) and 1 other predicate after a 314-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Dec 9, 2014
- Review
- 314 days
- Class
- Class II
- Product code
- LKO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922833 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922833 | Quanta Lite RNP Elisa | Inova Diagnostics, Inc. | 1992 | — |
| −1 | K123261 | Euroimmun Anti-NRNP/SM Elisa (Igg) | Euroimmun US | 2013 | — |
| 0 (this device) | K140224 | Euroimmun Euroline Ena Profile 9AG (Igg) | Euroimmun US | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 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 LKO? 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? (2)
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 |
|---|---|---|---|
| * | K123261 | Euroimmun Anti-NRNP/SM Elisa (Igg)Summary page 5…o. Profile 9 Ag (IgG) Antigens nRNP/Sm EUROIMMUN Anti-nRNP/Sm ELISA (IgG) k123261 Sm EUROIMMUN Anti-Sm ELISA (IgG) k123261… | 2013 |
| * | K063565 | Quanta Lite SS-a 52 ElisaSummary page 5…S-A ELISA (IgG) k123261 Ro-52 Inova Quanta Lite™ SS-A 52 ELISA k063565 SS-B EUROIMMUN Anti-SS-B ELISA (IgG) k123261… | 2007 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 20.7 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All LKO devicesLKO Anti-Rnp Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LKO
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKO
Too few LKO 510(k)s in any year since 2007 to give a median.
Recalls per year · LKO
No recall names LKO since 2007.
Adverse event reports per year · LKO
No MAUDE report names LKO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 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 EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal P-proteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-/dermatomyositis, mixed connective tissue disease and…
Read the full statement (108 words)
The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal P-proteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-/dermatomyositis, mixed connective tissue disease and Sjogren’s syndrome, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) test kit is intended to be used in a clinical, reference or hospital laboratory. This kit is not designed for point-of-care testing.
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/K140224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140224: Euroimmun Euroline Ena Profile 9AG (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140224
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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