# K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295

- Pathway: 510(k) (Traditional)
- Applicant: Light Diagnostics
- Decided: Oct 19, 1999 after 273 days
- Product code: GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster)
- Device class: 2
- Regulation: 21 CFR 866.3900
- 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 K951799 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay, Light Diagnostics (1996) Summary page 3.
- (no number) Bartels HSV Fluorescent Monoclonal Antibody Test: named in the summary without a submission number
- (no number) Meridian Merifluor™ VZV: named in the summary without a submission number
- (no number) DPC PathoDx® Herpes Typing Kit: named in the summary without a submission number

## Most influential descendants
- K070206: Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000 (2007), 0 descendants of its own

## Indications for use
Light Diagnostics SimulFluor™ HSV/VZV immunofluorescence Assay is a direct immunofluorescence test intended for the simultaneous detection and identification of HSV 1 and 2 and varicella-zoster virus (VZV) from patients with vesicular, oral, genital, or skin lesions, and following amplification of virus in culture. Specimens found to be negative on direct specimen examination should be tested by cell culture.

Source page: https://510kreport.com/device/K990141
Methodology: https://510kreport.com/methodology