510(k) · Cleared
ClearedAeskulisa Ana Hep-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesku, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Jun 23, 2004 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 23, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040953 Aeskulisa Ana Hep-2Aesku, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK131330 Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa…Gold Standard Diagnostics · 2014
Most influential descendants
Showing 1 of 1 · See all- K131330Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitGold Standard Diagnostics · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040953 | Aeskulisa Ana Hep-2 | Aesku, Inc. | 2004 | — |
| +1 | K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit | Gold Standard Diagnostics | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 LJM? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test Kit | 2014 | 0 |
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, K131330 (Gold Standard Diagnostics, 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJM devicesLJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LJM
265in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJM
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJM
No MAUDE report names LJM 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 | — | 2 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 3 | 265 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 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?
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp-2 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/K040953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040953: Aeskulisa Ana Hep-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040953
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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