# K072178: Athena Multi-Lyte HSV 1 & 2 Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: May 30, 2008 after 298 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 Zeus Scientific, Inc. AtheNA Multi-Lyte® HSV 1 & 2 IgG Test System is intended for the qualitative detection of the presence or absence of human IgG class antibodies to Herpes Simplex virus I and 2 in human sera. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and 2. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment.

Source page: https://510kreport.com/device/K072178
Methodology: https://510kreport.com/methodology