# K090073: D3 Dfa Metapneumovirus Identification Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Mar 6, 2009 after 53 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: 2 generations back to DEN070013 (2008). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082688: Pro HMPV+ Assay, Prodesse, Inc. (2008) Summary page 1.

## Most influential descendants
- K093233: D3 Fastpoint L-Dfa RSV/MVP 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. device, D 3 DFA Metapneumovirus Identification Kit, is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture. The assay detects hMPV antigens by immunofluorescence using a blend of three monoclonal antibodies (MAbs), from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by an FDA cleared hMPV molecular assay.

Source page: https://510kreport.com/device/K090073
Methodology: https://510kreport.com/methodology