# K171974: Solana RSV+hMPV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Oct 16, 2017 after 108 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid 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: 5 generations back to DEN070013 (2008). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131813: Quidel Molecular RSV + HMPV Assay, Quidel Corp. (2013) Summary page 7.

## Indications for use
The Solana RSV+hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral 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. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.

Source page: https://510kreport.com/device/K171974
Methodology: https://510kreport.com/methodology