510(k) · Cleared
ClearedQuickvue RSV 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Sep 24, 2010 as substantially equivalent to K061008 (Quidel Corp., 2006) and 1 other predicate after a 77-day review. Its family tree reaches back 5 generations to 1988. 4 later devices descend from it.
- Decided
- Sep 24, 2010
- Review
- 77 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K882629 (1988). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- 4 generations backK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
- 3 generations backK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003 · Recalled
- 2 generations backK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
- 1 generation backK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
- This deviceK101918 Quickvue RSV 10Quidel Corp. · 2010
- Descendant · cites it directly · 2 of its ownK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012
- Descendant · 2 generations on · 1 of its ownK130398 Sofia (R) RSV FiaQuidel Corp. · 2013
- Descendant · 3 generations on · 0 of its ownK162911 Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK132456 BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company · 2013
Most influential descendants
Showing 4 of 4 · See all- K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012 · cites it directly2descendants
- K130398Sofia (R) RSV FiaQuidel Corp. · 2013 · 2 generations on1descendant
- K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · 3 generations on0descendants
- K132456BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882629 | Directigen Respiratory Syncytial Virus Test Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| −4 | K022133 | BD Directigen EZ RSV Kit | Becton, Dickinson & CO | 2002 | 1 |
| −3 | K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory… | Binax, Inc. | 2003 | 2 |
| −2 | K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 | Quidel Corp. | 2006 | — |
| −1 | K070747 | Quick Vue RSV Test, Models 20193, 20199 | Quidel Corp. | 2007 | — |
| 0 (this device) | K101918 | Quickvue RSV 10 | Quidel Corp. | 2010 | — |
| +1 | K121633 | BD Veritor (TM) System for the Rapid Detection of RSV | Becton, Dickinson and Company | 2012 | — |
| +2 | K130398 | Sofia (R) RSV Fia | Quidel Corp. | 2013 | — |
| +3 | K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017 | 1 |
| +1 | K132456 | BD Veritor (TM) System for Rapid Detection of RSV | Becton, Dickinson and Company | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GQG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GQG device
- #1 K253318 Clungene RSV Antigen Rapid Testscore 10.8 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Summary page 1…evice Trade Name: QuickVue® RSV 10 Common Name: Respiratory Syncytial Virus (RSV) Test Predicate Device: QuickVue RSV test (K061008 and K070747) Device Classification/Name: 21 CFR 866.3480 / Respiratory syncytial virus serolog… | 2006 |
| * | K070747 | Quick Vue RSV Test, Models 20193, 20199Summary page 1…Name: QuickVue® RSV 10 Common Name: Respiratory Syncytial Virus (RSV) Test Predicate Device: QuickVue RSV test (K061008 and K070747) Device Classification/Name: 21 CFR 866.3480 / Respiratory syncytial virus serological reagent… | 2007 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K121633 (Becton, Dickinson and Company, 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K061008.
How does its category compare?
All GQG devicesGQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GQG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GQG
93in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GQG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GQG
2in 2025
MAUDE reports naming product code GQG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 93 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101918: Quickvue RSV 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101918
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026