Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA— 510(k) K254264
Substantially EquivalentOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)
FDA 510(k) clearance K254264 for Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA, Substantially Equivalent on 2026-09-04. Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Device class: 2.
Summary
This Ortho-Clinical Diagnostics (QuidelOrtho) clearance covers two tests: Sofia 2 SARS Antigen+ FIA and Sofia 2 Lyme FIA. Product code QVF is simple point-of-care devices that directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. The record carries no separate code for the Lyme test.
Class II, 21 CFR 866.3982. Microbiology is both the classification panel and the review panel, and the submission type is listed as Dual Track.
The applicant filed from San Diego, California. The decision came 248 calendar days after receipt (December 30, 2025 to September 4, 2026).
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Product code
- Product code QVF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3982
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- San Diego, CA, US
Recent devices under product code QVF
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