510(k) · Cleared
ClearedSofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Cleared on Sep 4, 2026 as substantially equivalent to DEN220039 (Quidel Corporation, 2023) after a 248-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Sep 4, 2026
- Review
- 248 days
- Class
- Class II
- Product code
- QVF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220039 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- This deviceK254264 Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023 | — |
| 0 (this device) | K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026 | — |
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 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
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 |
|---|---|---|---|
| * | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetSummary page 7…hemistry Sofia 2 510(k) 510(k) Summary Page 1 Predicate Device Predicate Device #: DEN220039, Predicate Trade Name: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set, Product Code: QVF Device Descrip… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN220039.
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. 2026, 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. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested…
Read the full statement (326 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. The test is intended for use as an aid in the
diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three
days with at least 48 hours between tests; or when tested once, and negative by the Sofia 2 SARS Antigen+ FIA and
followed up with a molecular test.
The test does not differentiate between SARS-CoV and SARS-CoV-2.
A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be
confirmed by a molecular SARS-CoV-2 assay.
Positive results do not rule out co-infection with other respiratory pathogens and should not be used as the sole basis for
diagnosis, treatment, or other patient management decisions.
Performance characteristics were established from August 2021 to November 2022 when SARS-CoV-2 Delta and Omicron
were the predominant SARS-CoV-2 variants in circulation. When other variants are emerging, performance characteristics
may vary.
The Sofia 2 Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to
Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection of at least 2
weeks’ duration. The Sofia 2 Lyme FIA is intended for use as an aid in diagnosis of Lyme disease. A negative result does not
preclude infection with B. burgdorferi. Positive results must be confirmed by testing with a corresponding second-tier B.
burgdorferi Western blot assay. Test results are to be used in conjunction with information obtained from the patient’s clinical
evaluation and other diagnostic procedures. The assay is to be performed on the Sofia 2 instrument. Professional guidelines
should be consulted regarding testing and treatment for Lyme disease when acute B. burgdorferi infection is suspected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254264: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254264
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026