# K093233: D3 Fastpoint L-Dfa RSV/MVP Identification Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Dec 4, 2009 after 51 days
- Product code: OMG (Antisera, Fluorescent, Human Metapneumovirus)
- Device class: 2
- Regulation: 21 CFR 866.3980
- 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 5.
- K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit, Diagnostic Hybrids, Inc. (2008) Summary page 2.
- K090073: D3 Dfa Metapneumovirus Identification Kit, Diagnostic Hybrids, Inc. (2009) Summary page 3.

## Indications for use
The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for respiratory syncytial virus after examination of the direct specimen result be confirmed by cell culture. Specimens found to be negative for human metapneumovirus after examination of the direct specimen results should be confirmed by an FDA-cleared human metapneurnovirus molecular assay. Negative results do not preclude respiratory syncytial virus and human metapneumovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

Source page: https://510kreport.com/device/K093233
Methodology: https://510kreport.com/methodology