# K063798: Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Sep 21, 2007 after 273 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
Longest line of descent: 1 generation back to K880157 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902662: Bartels Herpes Simplex Vir Flu Mono Antibody Test, Baxter Healthcare Corp (1990) Summary page 1.
- K904167: Pathodx Herpes Typing, Diagnostic Products Corp. (1990) Summary page 1.
- K880157: Microtrak HSV 1/HSV 2 Culture Identi./Typing Test, Syva Co. (1988) Summary page 1.

## Indications for use
The Diagnostic Hybrids D 3 DFA Herpes Simplex Virus Identification Kit is intended for use in the qualitative detection of human herpes simplex virus (HSV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Performance using direct specimen testing has not been evaluated.

Source page: https://510kreport.com/device/K063798
Methodology: https://510kreport.com/methodology