# K030863: Ebv Vca-P18 Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Panbio Limited
- Decided: Jun 27, 2003 after 101 days
- Product code: LSE (Epstein-Barr Virus, Other)
- 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 EBV VCA IgG ELISA: named in the summary without a submission number

## Indications for use
The Epstein Barr Virus Viral Capsid-pl8 Antigen (EBV VCA-p18) 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-p18 IgG ELISA should be used in conjunction with other EBV serologies.

Source page: https://510kreport.com/device/K030863
Methodology: https://510kreport.com/methodology