# K991880: Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay

- Pathway: 510(k) (Traditional)
- Applicant: Light Diagnostics
- Decided: Nov 9, 1999 after 160 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. The FDA summary names its predicate without a number.
- (no number) Bartels Herpes Simplex Virus Type-Specific Fluorescent Monoclonal Antibody Test (HSV Typing): named in the summary without a submission number
- (no number) DPC PathoDx® Herpes Typing Kit: named in the summary without a submission number

## Indications for use
Light Diagnostics SimulFluor™ HSV1/2 Immunofluorescence Assay is a direct immunofluorescence test intended for the detection and identification of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) following amplification in cell culture or by direct examination of clinical specimens prepared by cytospin. Specimens found to be negative on direct specimen examination should be tested by cell culture. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K991880
Methodology: https://510kreport.com/methodology