# K220923: Elecsys HSV-1 IgG (08948844160)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 12, 2022 after 195 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: 3 generations back to K052133 (2005). 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)
- K120625: Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV, Roche Diagnostics (2012) Summary page 4.

## Indications for use
Immunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-1 in human serum and lithium-hepain plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive and negative results depends on the population's prevalence and the pretest likelihood of HSV-1. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay 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, immunocompromised patients, or for use at point-of-care facilities.

Source page: https://510kreport.com/device/K220923
Methodology: https://510kreport.com/methodology