# K082688: Pro HMPV+ Assay

- Pathway: 510(k) (Traditional)
- Applicant: Prodesse, Inc.
- Decided: Nov 7, 2008 after 53 days
- Product code: OEM (Human Metapneumovirus (Hmpv) Rna Assay System)
- 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: 1 generation back to DEN070013 (2008). 1 ancestor in all.
15 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN070013: ID-Tag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008). Our reading of the summary gave K063765, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070013, ID-Tag Respiratory Viral Panel (Luminex Molecular Diagnostics, Inc.), granted Jan 3, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K131813: Quidel Molecular RSV + HMPV Assay (2013), 7 descendants of its own
- K161375: Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (2016), 4 descendants of its own
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (2018), 3 descendants of its own
- K112490: Quidel Molecular HMPV Assay (2011), 2 descendants of its own
- K090073: D3 Dfa Metapneumovirus Identification Kit (2009), 2 descendants of its own

## Indications for use
The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four 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.

Source page: https://510kreport.com/device/K082688
Methodology: https://510kreport.com/methodology