De Novo · Granted
GrantedSofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Granted on Mar 8, 2023 as a new device type through De Novo after a 265-day review. 12 later devices descend from it.
- Decided
- Mar 8, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- QVF
- Recalls
- None
12 later devices descend from it, 5 citing it directly.
- This deviceDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- Descendant · cites it directly · 4 of its ownK231187 Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation · 2024
- Descendant · cites it directly · 3 of its ownK221925 ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK223783 cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK254264 Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026
- Descendant · 2 generations on · 0 of its ownK262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW…Abbott Diagnostics Scarborough, Inc. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation · 2024 · cites it directly4descendants
- K221925ID Now Covid-19 2.0Abbott Diagnostics Scarborough, Inc. · 2023 · cites it directly3descendants
- K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2023 · 2 generations on1descendant
- K254264Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026 · cites it directly0descendants
- K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023 | — |
| +1 | K231187 | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | 2024 | — |
| +1 | K221925 | ID Now Covid-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2023 | 2 |
| +2 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2023 | — |
| +1 | K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026 | — |
| +2 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo 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 QVF? 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 QVF device
- #1 K231187 Nano-Check™ COVID-19 Antigen Testscore 18.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (12)
See all 125 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?
- Of its descendants, K231187 (Nano-Ditech Corporation, 2024) has gone furthest, with 4 descendants of its own.
How does its category compare?
All QVF devicesQVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QVF
180in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QVF
No recall names QVF since 2007.
Adverse event reports per year · QVF
No MAUDE report names QVF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 272 | 0 | 0 |
| 2025 | 3 | 180 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset. The test is intended for use as an aid in the diagnosis of…
Read the full statement (202 words)
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.
The test does not differentiate between SARS-CoV and SARS-CoV-2.
A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions.
Positive results do not rule out co-infection with other respiratory pathogens.
Performance characteristics for SARS-CoV-2 were established during the 2021-2022 SARS-CoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variant are emerging, performance characteristics may vary.
This test is intended for prescription use only and can be used in Point-of-Care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220039 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220039
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