# K070747: Quick Vue RSV Test, Models 20193, 20199

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Apr 23, 2007 after 35 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: 4 generations back to K882629 (1988). 4 ancestors in all.
5 later devices descend from it; 1 cites 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.

## Most influential descendants
- K101918: Quickvue RSV 10 (2010), 4 descendants of its own
- 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 test is a dipstick immunoassay which allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger). The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude RSV infection and it is recommended that they not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Source page: https://510kreport.com/device/K070747
Methodology: https://510kreport.com/methodology