510(k) · Cleared
ClearedAeskulisa Ana Hep-2, Ref 30-7115US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesku Diagnostics · LKJ Antinuclear Antibody, Antigen, Control
Cleared on May 2, 2008 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- May 2, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081104 | Aeskulisa Ana Hep-2, Ref 30-7115US | Aesku Diagnostics | 2008 | — |
| +1 | K131185 | Ana Screen Elisa (Igg) | Euroimmun US | 2013 | — |
| +1 | K112996 | Euroimmun Anti-Ena Pool Elisa (Igg) | Euroimmun US | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKJ device
- #1 K210902 EliA Ro52, EliA Ro60score 4.0 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K131185 (Euroimmun US, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LKJ devicesLKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LKJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LKJ
Too few LKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKJ
2in 2018
MAUDE reports naming product code LKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 7 | 2 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 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?
AESKUUSA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT).
The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081104: Aeskulisa Ana Hep-2, Ref 30-7115US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081104
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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