# K123838: Pro HMPV+ Assay

- Pathway: 510(k) (Special)
- Applicant: Gen-Probe Prodesse, Inc.
- Decided: Jan 16, 2013 after 34 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: 3 generations back to DEN070013 (2008). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K112490: Quidel Molecular HMPV Assay, Quidel Corp. (2011)
- K081483: Xtag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008) Summary page 1.
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116, Luminex Molecular Diagnostics, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K063765: Luminex RVP Assay. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K132200: Pro HMPV+ Assay (2013), 0 descendants of its own

## Indications for use
The Prodesse Pro hMPV+ Assay is a Real-Time PCR (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/K123838
Methodology: https://510kreport.com/methodology