510(k) · Cleared
ClearedSofia (R) RSV Fia
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 Aug 13, 2013 as substantially equivalent to K121633 (Becton, Dickinson and Company, 2012) after a 175-day review. Its family tree reaches back 7 generations to 1988. 1 later device descends from it.
- Decided
- Aug 13, 2013
- Review
- 175 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K882629 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- 6 generations backK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
- 5 generations backK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003 · Recalled
- 4 generations backK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
- 3 generations backK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
- 2 generations backK101918 Quickvue RSV 10Quidel Corp. · 2010
- 1 generation backK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012
- This deviceK130398 Sofia (R) RSV FiaQuidel Corp. · 2013
- Descendant · cites it directly · 0 of its ownK162911 Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882629 | Directigen Respiratory Syncytial Virus Test Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| −6 | K022133 | BD Directigen EZ RSV Kit | Becton, Dickinson & CO | 2002 | 1 |
| −5 | K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory… | Binax, Inc. | 2003 | 2 |
| −4 | K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 | Quidel Corp. | 2006 | — |
| −3 | K070747 | Quick Vue RSV Test, Models 20193, 20199 | Quidel Corp. | 2007 | — |
| −2 | K101918 | Quickvue RSV 10 | Quidel Corp. | 2010 | — |
| −1 | K121633 | BD Veritor (TM) System for the Rapid Detection of RSV | Becton, Dickinson and Company | 2012 | — |
| 0 (this device) | K130398 | Sofia (R) RSV Fia | Quidel Corp. | 2013 | — |
| +1 | K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121633 | BD Veritor (TM) System for the Rapid Detection of RSVSummary page 1…: Respiratory Syncytial Virus (RSV) Test Predicate Device: BD VeritorTM System for Rapid Detection of RSV, K12 1633 Device Classification/Name: 21 CER 866.3480 / Respiratory syncytial virus serological reagents… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | 2017 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K162911 (Quidel Corporation, 2017) has gone furthest, with 0 descendants of its own.
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. 2013, 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 Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. 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 result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130398: Sofia (R) RSV Fia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130398
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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