# K020706: Ebv-Vca Igg Elisa Test, Model Ebg-100

- Pathway: 510(k) (Traditional)
- Applicant: Pan Bio Pty., Ltd.
- Decided: Jun 13, 2002 after 101 days
- Product code: GNP (Antiserum, Cf, 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.
No later device cites it as a predicate yet.
0 of 1 device 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) DiaSorin Incstar EBV-VCA IgG ELISA: named in the summary without a submission number

## Indications for use
The Epstein Barr Virus Viral Capsid Antigen (EBV-VCA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV-VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV-VCA IgG ELISA should be used in conjunction with other EBV serologies

Source page: https://510kreport.com/device/K020706
Methodology: https://510kreport.com/methodology