Clearance Summary
Sofia Lyme FIA; Sofia 2 Campylobacter FIA received FDA 510(k) clearance under submission number K254295, sponsored by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-07-10.
- Submission: K254295
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2026-07-10
Classification & Regulation
This clearance is catalogued under FDA product code LSR and 21 CFR 866.3830, within the Microbiology review panel as a Class II device.