# K093415: D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Dec 23, 2009 after 51 days
- Product code: GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4)
- Device class: 1
- Regulation: 21 CFR 866.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022713 (2002). 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)
- K061101: D3 Ultra Dfa Respiratory Virus Screening & ID Kit, Diagnostic Hybrids, Inc. (2006) Summary page 1.
- K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit, Diagnostic Hybrids, Inc. (2008) Summary page 2.

## Indications for use
The Diagnostic H-ybrids, Inc. device, D 3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of inmmuofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for parainfluenza virus and adenovirus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude parainfluenza virus and adenovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Source page: https://510kreport.com/device/K093415
Methodology: https://510kreport.com/methodology