# K101918: Quickvue RSV 10

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Sep 24, 2010 after 77 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- 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 K882629 (1988). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061008: Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199, Quidel Corp. (2006) Summary page 1.
- K070747: Quick Vue RSV Test, Models 20193, 20199, Quidel Corp. (2007) Summary page 1.

## Most influential descendants
- K121633: BD Veritor (TM) System for the Rapid Detection of RSV (2012), 2 descendants of its own
- K130398: Sofia (R) RSV Fia (2013), 1 descendant of its own
- K162911: Sofia RSV FIA on Sofia 2 analyzer (2017), 0 descendants of its own
- K132456: BD Veritor (TM) System for Rapid Detection of RSV (2013), 0 descendants of its own

## Indications for use
The QuickVue RSV 10 test is an immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (less than six years old). The test is intended for use as an aid in the rapid diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by cell culture. The test is intended for professional and laboratory use.

Source page: https://510kreport.com/device/K101918
Methodology: https://510kreport.com/methodology