# K971101: HSV-2 Antigen Control Slides

- Pathway: 510(k) (Traditional)
- Applicant: Viral Antigens, Inc.
- Decided: Jul 1, 1997 after 97 days
- Product code: GQN (Antigen, Cf (Including Cf Control), 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
In order to confirm HSV-2 infections physicians frequently use tissue culture techniques. This involves obtaining patient samples, inoculation of these samples into established cell lines (Such as MRC-5 cells) and monitoring these cells for HSV-2 induced cytopathology. Frequently the cells inoculated with patient sample are then stained as an aid in the diagnosis of HSV-2 infections. HSV-2 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-2. Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well. The two wells of cells on the HSV-2 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.

Source page: https://510kreport.com/device/K971101
Methodology: https://510kreport.com/methodology