# K971662: Elvis HSV ID/Typing Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Nov 18, 1997 after 203 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.
9 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HSV1/HSV2 Culture Identification/Typing Test: named in the summary without a submission number

## Most influential descendants
- K100336: Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711 (2010), 7 descendants of its own
- K140198: Imdx HSV-1/2 for Abbott M2000 (2014), 2 descendants of its own
- K142738: artus HSV-1/2 QS-RGQ MDx Kit (2014), 1 descendant of its own
- K111951: Isoamp HSV Assay (2011), 1 descendant of its own
- K172509: Sentosa SA201 HSV 1/2 Qualitative PCR Test (2018), 0 descendants of its own

## Indications for use
The ELVIS™ HSV ID/Typing Test System is a qualitative test indicated for use in the isolation and identification of HSV from lesions and body fluids suspected of containing viable HSV-1 and/or HSV-2. Both serotypes have been isolated from various parts of the body, particularly when HSV-associated disease is indicated. Performance of this assay has not been established for use with antiviral therapy or prenatal monitoring.

Source page: https://510kreport.com/device/K971662
Methodology: https://510kreport.com/methodology