# K061101: D3 Ultra Dfa Respiratory Virus Screening & ID Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Nov 20, 2006 after 214 days
- Product code: GNW (Antisera, Cf, Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- 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 K022713 (2002). 1 ancestor in all.
7 later devices descend from it; 7 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022713: Dfa Respiratory Virus Screening & ID Kit, Diagnostic Hybrids, Inc. (2002) Summary page 3.

## Most influential descendants
- K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit (2008), 4 descendants of its own
- K093415: D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit (2009), 0 descendants of its own
- K093233: D3 Fastpoint L-Dfa RSV/MVP Identification Kit (2009), 0 descendants of its own
- K092882: D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit (2009), 0 descendants of its own
- K091171: D3 Ultra Duet Dfa Respiratory Virus Identification Kit (2009), 0 descendants of its own

## Indications for use
The Diagnostic Hybrids, Inc.'s D 3 Ultra DFA (direct fluorescent antibody) RESPIRATORY VIRUS SCREENING & ID KIT is intended for the qualitative detection and identification of the Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 virus in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Source page: https://510kreport.com/device/K061101
Methodology: https://510kreport.com/methodology