# K073382: Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500G

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Jul 28, 2008 after 238 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) Diamedix EBV VCA IgG ELISA: named in the summary without a submission number
- (no number) Diamedix EBV EBNA-1 IgG ELISA: named in the summary without a submission number
- (no number) Diamedix EBV EA-D IgG ELISA: named in the summary without a submission number
- (no number) Athena Multi-Lyte Ebv Igg Test System: named in the summary without a submission number
- (no number) Focus EBV-VCA ANTIBODY (IGG) - IFA: named in the summary without a submission number

## Indications for use
Focus Diagnostics' PlexusTM EBV IgG Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgG class antibodies to viral capsid antigen (VCA), early antigen- diffuse (EA-D), and nuclear antigen (EBNA-1) of Epstein-Barr virus in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis. The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

Source page: https://510kreport.com/device/K073382
Methodology: https://510kreport.com/methodology