510(k) · Cleared
ClearedIfa 40: Hep-20-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun US · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Feb 26, 2014 as substantially equivalent to K972145 (Immuno Concepts, Inc., 1998) after a 253-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Feb 26, 2014
- Review
- 253 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935129 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK935129 Relisa Ena Antibody Screening Test SystemImmuno Concepts, Inc. · 1994 · Recalled
- 2 generations backK955603 Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc. · 1996
- 1 generation backK972145 Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998
- This deviceK131791 Ifa 40: Hep-20-10Euroimmun US · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935129 | Relisa Ena Antibody Screening Test System | Immuno Concepts, Inc. | 1994 | 1 |
| −2 | K955603 | Relsia SS-a/RO & SS/B LA Antibody Test System | Immuno Concepts, Inc. | 1996 | — |
| −1 | K972145 | Hep-2000 Fluorescent Ana-RO Test System | Immuno Concepts, Inc. | 1998 | — |
| 0 (this device) | K131791 | Ifa 40: Hep-20-10 | Euroimmun US | 2014 | — |
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 DHN? 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 |
|---|---|---|---|
| * | K972145 | Hep-2000 Fluorescent Ana-RO Test SystemSummary page 2…tely. J. Substantial Equivalence Information: 1. Predicate device name () lmmuno~oncepts' Hep-2000 ANA-Ro IFA 2. Predicate 510(k) number(s): K9721 45 3. Comparison with Predicate: Similarities __________________________________________… | 1998 |
| † | K070763 | Euroimmun Ana Ifa: Hep-20-10 | 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 20 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K972145.
How does its category compare?
All DHN devicesDHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DHN
Too few DHN 510(k)s in any year since 2007 to give a median.
Recalls per year · DHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHN
No MAUDE report names DHN 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 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131791: Ifa 40: Hep-20-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131791
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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