# K020717: Ebv V Vca Igm Elisa Kit Model# Ebm-200

- Pathway: 510(k) (Traditional)
- Applicant: Pan Bio Pty., Ltd.
- Decided: Jun 13, 2002 after 100 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 IgM ELISA: named in the summary without a submission number

## Indications for use
The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM 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 PANBlO EBV VCA IgM ELISA should be used in conjunction with other EBV serology.

Source page: https://510kreport.com/device/K020717
Methodology: https://510kreport.com/methodology