# K946158: Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Jun 9, 1995 after 183 days
- Product code: LLM (Test, Antigen, Nuclear, Epstein-Barr Virus)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040120: Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays (2005), 4 descendants of its own
- K233606: ADVIA Centaur EBV-VCA IgM (2024), 0 descendants of its own
- K233605: ADVIA Centaur EBV-EBNA IgG (2024), 0 descendants of its own
- K162961: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (2017), 0 descendants of its own
- K161522: LIAISON EBV IgM Serum Control Set (2016), 0 descendants of its own

## Recalls of this device
- Mar 14, 2007 · Not classified · Z-0755-2007: A lot to lot inconsistency was noted on kits of ETI EBNA G.

Source page: https://510kreport.com/device/K946158
Methodology: https://510kreport.com/methodology