510(k) · Cleared
ClearedIncstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incstar Corp. · LSE Epstein-Barr Virus, Other
Cleared on Jun 7, 1995 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 7, 1995
- Review
- 181 days
- Class
- Class I
- Product code
- LSE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK946159 Incstar Epstein-Barr Viral Capsid Antigen (Vca) 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
Most influential descendants
Showing 5 of 5 · 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) | K946159 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) 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 |
|---|---|---|
| 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 LSE? 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 LSE device
- #1 K233606 ADVIA Centaur EBV-VCA IgMscore 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays | 2005 | 4 |
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, K040120 (DiaSorin, Inc., 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LSE devicesLSE Epstein-Barr Virus, Other: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSE
Too few LSE 510(k)s in any year since 2007 to give a median.
Recalls per year · LSE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSE
1in 2014
MAUDE reports naming product code LSE, 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 | — | 2 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 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 | — | 1 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K946159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946159: Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946159
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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