# K092300: Modification to D3 Ultra Dfa Respiratory Virus Screening & ID Kit

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Aug 28, 2009 after 30 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: 2 generations back to K022713 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061101: D3 Ultra Dfa Respiratory Virus Screening & ID Kit, Diagnostic Hybrids, Inc. (2006) Summary page 1.

## Indications for use
The Diagnostic Hybrids, Inc. 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. Performance characteristics for influenza A were established when influenza A/H3 and A/HI were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility' is available to receive and culture specimens. 2

Source page: https://510kreport.com/device/K092300
Methodology: https://510kreport.com/methodology