Sofia Lyme FIA; Sofia 2 Campylobacter FIA— 510(k) K254295
Substantially EquivalentOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)
FDA 510(k) clearance K254295 for Sofia Lyme FIA; Sofia 2 Campylobacter FIA, Substantially Equivalent on 2026-07-10. Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Device class: 2.
Summary
Ortho-Clinical Diagnostics (QuidelOrtho) has two tests in this clearance: Sofia Lyme FIA and Sofia 2 Campylobacter FIA. They're filed under LSR, Borrelia serological reagents; the record carries no separate code for the Campylobacter test.
Class II, 21 CFR 866.3830. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from San Diego, California. The decision came 191 calendar days after FDA received it (December 31, 2025 to July 10, 2026).
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Product code
- Product code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LSR
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