# K993754: HSV-1 Elisa Igg, Model EL0910G

- Pathway: 510(k) (Traditional)
- Applicant: Mrl Diagnostics
- Decided: Feb 9, 2000 after 96 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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-1 ELISA Test System, Zeus Scientific, Inc.: named in the summary without a submission number
- (no number) HSV-1 Western Blot, University of Washington: named in the summary without a submission number
- (no number) HSV-1 Culture, University of Washington: named in the summary without a submission number

## Indications for use
MRL Diagnostics' HSV-1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the MRL HSV-2 ELISA IgG, the test is indicated for 1) testing sexually active adults, with or without a clinical history of herpes, for aiding in the presumptive diagnosis of HSV infection to identify persons who are at risk for transmitting or acquiring HSV so they may be counseled, and 2) testing expectant mothers for aiding in the presumptive assessment of the risk for acquiring and/or transmitting HSV to their child, so they may be counseled.

Source page: https://510kreport.com/device/K993754
Methodology: https://510kreport.com/methodology