# K062543: Herpeselect  1 and 2 Plexus Igg, Model MP0900G

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Feb 1, 2007 after 155 days
- Product code: MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1)
- Device class: 2
- Regulation: 21 CFR 866.3305
- 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) HerpeSelect I and 2 Immunoblot IgG: named in the summary without a submission number
- (no number) HerpeSelect-1 ELISA IgG: named in the summary without a submission number
- (no number) HerpeSelect-2 ELISA IgG: named in the summary without a submission number

## Indications for use
Focus Diagnostics' Plexus HerpeSelect 1 and 2 IgG is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

Source page: https://510kreport.com/device/K062543
Methodology: https://510kreport.com/methodology