510(k) · Cleared
ClearedIncstar Epstein-Barr Viral Capsid Antigen (Vca) LGM 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. 7 later devices descend from it.
- Decided
- Jun 7, 1995
- Review
- 181 days
- Class
- Class I
- Product code
- LSE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK946157 Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM 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 · cites it directly · 1 of its ownK062213 Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2006 · Recalled
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040120Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc. · 2005 · cites it directly4descendants
- K062213Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc. · 2006 · cites it directly1descendant
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946157 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit | Incstar Corp. | 1995 | — |
| +1 | K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays | DiaSorin, Inc. | 2005 | — |
| +1 | K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories, Inc. | 2006 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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? (7)
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, 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/K946157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946157: Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM 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/K946157
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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