510(k) · Cleared
Recalled · Class II · 2017Sofia RSV FIA on Sofia 2 analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Feb 22, 2017 as substantially equivalent to K130398 (Quidel Corp., 2013) after a 128-day review. Its family tree reaches back 8 generations to 1988. It has been recalled once.
- Decided
- Feb 22, 2017
- Review
- 128 days
- Class
- Class I
- Product code
- GQG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K882629 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- 7 generations backK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
- 6 generations backK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003 · Recalled
- 5 generations backK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
- 4 generations backK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
- 3 generations backK101918 Quickvue RSV 10Quidel Corp. · 2010
- 2 generations backK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012
- 1 generation backK130398 Sofia (R) RSV FiaQuidel Corp. · 2013
- This deviceK162911 Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882629 | Directigen Respiratory Syncytial Virus Test Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| −7 | K022133 | BD Directigen EZ RSV Kit | Becton, Dickinson & CO | 2002 | 1 |
| −6 | K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory… | Binax, Inc. | 2003 | 2 |
| −5 | K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 | Quidel Corp. | 2006 | — |
| −4 | K070747 | Quick Vue RSV Test, Models 20193, 20199 | Quidel Corp. | 2007 | — |
| −3 | K101918 | Quickvue RSV 10 | Quidel Corp. | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | K162911 | Sofia RSV FIA on Sofia 2 analyzer | Quidel Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K130398 | Sofia (R) RSV FiaSummary page 6…Sofia or Sofia 2. 5.10. Substantial Equivalence Information: 1. Predicate Device Name: Sofia RSV FIA performed on Sofia 2. Predicate 510(k) Numbers: K130398 3. Comparison with Predicate: Sofia® 2 for use with the Sofia RSV FIA 510(k) VOLUME 1… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2017 | Class II | Z-1183-2018 | Software Manufacturing/Software Deployment | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
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. 2017, 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. 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 viral culture or an FDA-cleared RSV molecular assay.
The Sofia RSV FIA may be used with the Sofia or Sofia 2.
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/K162911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162911: Sofia RSV FIA on Sofia 2 analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162911
Report an extraction error
Are you the manufacturer?
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