# K121895: Elecsys HSV-2 Igg Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 24, 2012 after 56 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K052133 (2005). 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)
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G, Mrl Diagnostics (2000) Summary page 1.
- K081338: Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP, Roche Diagnostics (2008) Summary page 14.

## Most influential descendants
- K220924: Elecsys HSV-2 IgG (08948887160) (2022), 0 descendants of its own

## Indications for use
The Roche Elecsys HSV-2 IgG inmmoassay is a test for the in vitro qualitative determination of JgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2 -EDTA plasma, and K3 -EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of H-SV-2. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e inmmnoassay analyzers. This 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 inmmocompromised patients or for use at point of care facilities. The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K121895
Methodology: https://510kreport.com/methodology