# K254264: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

- Pathway: 510(k) (Dual Track)
- Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Decided: Sep 4, 2026 after 248 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 7.

## 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. 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.

Source page: https://510kreport.com/device/K254264
Methodology: https://510kreport.com/methodology