# K073381: Plexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600M

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Aug 4, 2008 after 245 days
- Product code: LJN (Antibody Igm, If, 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) Osom® Mono Test: named in the summary without a submission number
- (no number) Diamedix EBV VCA IgM ELISA: named in the summary without a submission number
- (no number) Athena Multi-Lyte EBV VCA IgM Test System: named in the summary without a submission number
- (no number) Epstein-Barr Virus VCA (IgM) Recomb Immun Antibod (IFA): named in the summary without a submission number

## Indications for use
Focus Diagnostics' PlexusTM EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies 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/K073381
Methodology: https://510kreport.com/methodology