# K090409: Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: May 8, 2009 after 79 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
Longest line of descent: 1 generation back to K000238 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021429: Herpeselect 1 Elisa Igg, Model EL0910G, Focus Technologies, Inc. (2002) Summary page 2.
- K021486: Herpeselect 2 Elisa Igg, Model ELO920G, Focus Technologies, Inc. (2002) Summary page 2.
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G, Mrl Diagnostics (2000) Summary page 2.

## Most influential descendants
- K120959: Bioplex 2200 HSV-1 and HSV-2 Igg Kit (2012), 0 descendants of its own

## Indications for use
The BioPlexTM 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-I or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV- 1 and HSV-2. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities. The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

Source page: https://510kreport.com/device/K090409
Methodology: https://510kreport.com/methodology