# K122189: Quidel Molecular RSV + HMPV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Mar 8, 2013 after 227 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: 4 generations back to DEN070013 (2008). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092500: Modification to Proflu+ Assay, Prodesse, Inc. (2009) Summary page 1.
- K082688: Pro HMPV+ Assay, Prodesse, Inc. (2008) Summary page 2.

## Indications for use
The Quidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the qualitative detection and identification of respiratory syncytial virus and human metapneumovirus RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or 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/K122189
Methodology: https://510kreport.com/methodology