Clearance Summary
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA received FDA 510(k) clearance under submission number K254264, sponsored by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-09-04.
- Submission: K254264
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3982
- Decision date: 2026-09-04
Classification & Regulation
This clearance is catalogued under FDA product code QVF and 21 CFR 866.3982, within the Microbiology review panel as a Class II device.