# K951549: Ebna Igg Eia Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immunoprobe, Inc.
- Decided: Apr 29, 1996 after 391 days
- Product code: LLM (Test, Antigen, Nuclear, Epstein-Barr Virus)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BioWhitttaker’s EBNA STAT test: named in the summary without a submission number

## Most influential descendants
- K062211: Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System (2006), 1 descendant of its own
- K120439: Bioplex 2200 Ebv Igg and Syphilis Igg (2012), 0 descendants of its own

## Indications for use
The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosts.

Source page: https://510kreport.com/device/K951549
Methodology: https://510kreport.com/methodology