# K120959: Bioplex 2200 HSV-1 and HSV-2 Igg Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jun 22, 2012 after 84 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: 2 generations back to K000238 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090409: Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System, Bio-Rad Laboratories (2009) Summary page 2.

## Indications for use
The Biolex® 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-1I or 1-SV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of IISV-lI 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 Biolex® 2200 US V-i & HSV-2 IgG kit is intended for use with the Bid-Rad Biolex®'2200 System. The Biolex® 2200 IISV-1 & HSV-2 IgG Calibrator Set is intended for the calibration of the Bioex® 2200 HSV-1 & HSV-2 IgG Reagent Pack. The Biollex® 2200 HS-1 VI & HSV-2 IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the Biolex®'2200 Instrument and Biolex® 2200 HSV-1 & HSV-2 IgG Reagent Pack in the clinical laboratory. The performance of the Biolex® 2200 HSV-I & HSV-2 IgO Control Set has not been established with any other HSV-1I and HSV-2 antibody assays.

Source page: https://510kreport.com/device/K120959
Methodology: https://510kreport.com/methodology