# K093784: Athena Multi-Lyte Torch Igg Plus Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 16, 2010 after 219 days
- Product code: OPM (Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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 K891781 (1989). 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)
- K891781: Toxo Elisa Test System, Zeus Scientific, Inc. (1989) Summary page 3.
- K891783: Rubella Elisa Test System, Zeus Scientific, Inc. (1989) Summary page 3.
- K924096: CMV Elisa Test System, Zeus Scientific, Inc. (1993) Summary page 4.
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G, Mrl Diagnostics (2000) Summary page 4.

## Indications for use
The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH lgG Plus Test System is intended for the qualitative detection of specific human lgG class antibodies to Toxoplasma gondil (T.gondii), Rubella, Cytomnegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CIMV. For HSV 1 and HSV 2, the test isindicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex l and Herpes Simplex 2. The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.

Source page: https://510kreport.com/device/K093784
Methodology: https://510kreport.com/methodology