# K112490: Quidel Molecular HMPV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Dec 15, 2011 after 108 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: 2 generations back to DEN070013 (2008). 2 ancestors in all.
2 later devices descend from it; 1 cites 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
- K123838: Pro HMPV+ Assay (2013), 1 descendant of its own
- K132200: Pro HMPV+ Assay (2013), 0 descendants of its own

## Indications for use
The Quidel Molecular hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection of human metapneumnovirus RNA in nasal and nasopharyngeal swab specimens from patients with signs and symptomjs of respiratory infection. This test is intended for use as an aid in the differential diagnosis of human mnetapneumnovirus infections in humans in conjunction with clinical and epidemiological risk factors. 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 patient management decisions.

Source page: https://510kreport.com/device/K112490
Methodology: https://510kreport.com/methodology