510(k) · Cleared
Recalled · 2007Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incstar Corp. · LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Cleared on Jun 9, 1995 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 9, 1995
- Review
- 183 days
- Class
- Class I
- Product code
- LLM
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK946158 Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitIncstar Corp. · 1995
- Descendant · cites it directly · 4 of its ownK040120 Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK233606 ADVIA Centaur EBV-VCA IgMBiokit, S.A. · 2024
- Descendant · 2 generations on · 0 of its ownK233605 ADVIA Centaur EBV-EBNA IgGBiokit, S.A. · 2024
- Descendant · 2 generations on · 0 of its ownK162961 LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON®…DiaSorin, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK161522 LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040120Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc. · 2005 · cites it directly4descendants
- K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A. · 2024 · 2 generations on0descendants
- K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A. · 2024 · 2 generations on0descendants
- K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…DiaSorin, Inc. · 2017 · 2 generations on0descendants
- K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit | Incstar Corp. | 1995 | — |
| +1 | K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays | DiaSorin, Inc. | 2005 | — |
| +2 | K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | 2024 | — |
| +2 | K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | 2024 | — |
| +2 | K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and… | DiaSorin, Inc. | 2017 | — |
| +2 | K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLM? 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 LLM device
- #1 K233605 ADVIA Centaur EBV-EBNA IgGscore 8.1 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2007 | Not classified | Z-0755-2007 | Other | A lot to lot inconsistency was noted on kits of ETI EBNA G. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040120 (DiaSorin, Inc., 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LLM devicesLLM Test, Antigen, Nuclear, Epstein-Barr Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LLM
Too few LLM 510(k)s in any year since 2007 to give a median.
Recalls per year · LLM
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLM
No MAUDE report names LLM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K946158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946158: Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946158
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026