# DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

- Pathway: De Novo (Post-NSE)
- Applicant: Quidel Corporation
- Decided: Mar 8, 2023 after 265 days
- Product code: QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings)
- Device class: 2
- Regulation: 21 CFR 866.3982
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K231187: Nano-Check™ COVID-19 Antigen Test (2024), 4 descendants of its own
- K221925: ID Now Covid-19 2.0 (2023), 3 descendants of its own
- K223783: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (2023), 1 descendant of its own
- K254264: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA (2026), 0 descendants of its own
- K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN220039
Methodology: https://510kreport.com/methodology