# K233688: Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

- Pathway: 510(k) (Special)
- Applicant: Quidel Corporation
- Decided: Dec 13, 2023 after 26 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
Longest line of descent: 1 generation back to DEN220039 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set, Quidel Corporation (2023) Summary page 5.

## Indications for use
Sofia 2 SARS Antigen+ FIA: 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 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 it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with bacteria or other viruses and should not be used as the sole basis for treatment or other patient management decisions. 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. Sofia 2 SARS Antigen+ FIA Control Swab Set: The Sofia 2 SARS Antigen+ FIA Control Swabs are intended to be used as quality control samples with the Sofia 2 SARS Antigen+ FIA and are representative of positive and negative test samples. These Controls may be used to demonstrate that the reagents and assay procedure perform properly.

Source page: https://510kreport.com/device/K233688
Methodology: https://510kreport.com/methodology