# K091753: Elvis HSV ID and D3 Typing Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Aug 28, 2009 after 73 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
Longest line of descent: 1 generation back to K971662 (1997). 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)
- K971662: Elvis HSV ID/Typing Test System, Diagnostic Hybrids, Inc. (1997) Summary page 1.

## Indications for use
The ELVIS8-HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens as an aid in the diagnosis of HSV type 1 (HSV-1) and HSV type 2 (HSV-2) infections. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or use with cerebral spinal fluid specimens.

Source page: https://510kreport.com/device/K091753
Methodology: https://510kreport.com/methodology