# K061008: Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Sep 8, 2006 after 149 days
- Product code: MCE (Respiratory Syncytial Virus - Elisa)
- 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: 3 generations back to K882629 (1988). 3 ancestors in all.
6 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)
- K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065, Binax, Inc. (2003) Summary page 1.

## Most influential descendants
- K070747: Quick Vue RSV Test, Models 20193, 20199 (2007), 5 descendants of its own
- 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

## Indications for use
The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.

Source page: https://510kreport.com/device/K061008
Methodology: https://510kreport.com/methodology