510(k) · Cleared
ClearedBD Veritor (TM) System for the Rapid Detection of RSV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Sep 18, 2012 as substantially equivalent to K101918 (Quidel Corp., 2010) after a 106-day review. Its family tree reaches back 6 generations to 1988. 2 later devices descend from it.
- Decided
- Sep 18, 2012
- Review
- 106 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K882629 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- 5 generations backK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
- 4 generations backK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003 · Recalled
- 3 generations backK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
- 2 generations backK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
- 1 generation backK101918 Quickvue RSV 10Quidel Corp. · 2010
- This deviceK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012
- Descendant · cites it directly · 1 of its ownK130398 Sofia (R) RSV FiaQuidel Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK162911 Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882629 | Directigen Respiratory Syncytial Virus Test Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| −5 | K022133 | BD Directigen EZ RSV Kit | Becton, Dickinson & CO | 2002 | 1 |
| −4 | K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory… | Binax, Inc. | 2003 | 2 |
| −3 | K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 | Quidel Corp. | 2006 | — |
| −2 | K070747 | Quick Vue RSV Test, Models 20193, 20199 | Quidel Corp. | 2007 | — |
| −1 | K101918 | Quickvue RSV 10 | Quidel Corp. | 2010 | — |
| 0 (this device) | K121633 | BD Veritor (TM) System for the Rapid Detection of RSV | Becton, Dickinson and Company | 2012 | — |
| +1 | K130398 | Sofia (R) RSV Fia | Quidel Corp. | 2013 | — |
| +2 | K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K101918 | Quickvue RSV 10Summary page 2…ion of RSV Clinical Laboratory Product DEVICE COMPARISON: The BD Veritor~m System for Rapid Detection of RSV was compared to the Quidel QuickVue RSV 10 test (k101918) Product BID Veritorm System for RSV Quidel QuickView RSV l0atest (k101918) Feature ___________… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130398 | Sofia (R) RSV Fia | 2013 | 1 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K130398 (Quidel Corp., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K101918.
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. 2012, 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 BD Veritor System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and…
Read the full statement (149 words)
The BD Veritor System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 20 years. 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 viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor System Reader.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121633: BD Veritor (TM) System for the Rapid Detection of RSV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121633
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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