# K131334: Herpes Simplex Virus Type 1 Igg Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics
- Decided: Feb 28, 2014 after 295 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Gold Standard Diagnostics Herpes Simplex Virus Type I IgG ELISA Test Kit is intended for the qualitative detection of IgG antibodies to Herpes Simplex Virus Type I (HSV-1) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1. The test is not intended for screening of blood and plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Source page: https://510kreport.com/device/K131334
Methodology: https://510kreport.com/methodology