# K993724: HSV-2 Elisa Igg, Model EL0920G

- Pathway: 510(k) (Traditional)
- Applicant: Mrl Diagnostics
- Decided: Feb 1, 2000 after 90 days
- Product code: MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)
- 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HSV-2 ELISA Test System, Zeus Scientific, Inc.: named in the summary without a submission number
- (no number) HSV-2 Western Blot, University of Washington: named in the summary without a submission number
- (no number) HSV-2 Culture, University of Washington: named in the summary without a submission number

## Most influential descendants
- K031952: West Nile Virus Igm Capture Elisa, Model EL0300M (2003), 3 descendants of its own
- K040854: West Nile Virus Igm Capture Elisa (2004), 1 descendant of its own
- K031953: West Nile Virus Elisa Igg, Model EL0300G (2003), 1 descendant of its own
- K153308: EUROIMMUN Anti-West Nile Virus ELISA (IgM) (2016), 0 descendants of its own
- K153303: EUROIMMUN Anti-West Nile Virus ELISA (IgG) (2016), 0 descendants of its own

## Indications for use
MRL Diagnostics' HSV-2 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. In conjunction with the MRL HSV-1 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment.

Source page: https://510kreport.com/device/K993724
Methodology: https://510kreport.com/methodology