# K984120: The Aptus (Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: May 26, 1999 after 189 days
- Product code: GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2)
- 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-2 in human serum. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross reactivity of shared antigens, the HSV-1 IgG ELISA test should be performed in conjunction with this test system to fully evaluate the patient serum. The test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984120
Methodology: https://510kreport.com/methodology