Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA— 510(k) K254262
Substantially EquivalentOrtho Clinical Diagnostics Inc. (QuidelOrtho)
FDA 510(k) clearance K254262 for Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA, Substantially Equivalent on 2026-09-04. Applicant: Ortho Clinical Diagnostics Inc. (QuidelOrtho). Device class: 2.
Summary
This clearance covers three Sofia tests from Ortho Clinical Diagnostics (QuidelOrtho): Sofia Influenza A+B FIA, Sofia RSV FIA, and Sofia Strep A+ FIA. They're filed under PSZ, devices detecting influenza A, B, and C virus antigens, though only the first name refers to influenza.
Class II, 21 CFR 866.3328. Microbiology is both the classification panel and the review panel. The submission type is listed as Dual Track.
The applicant filed from San Diego, California. Review took 248 calendar days (December 30, 2025 to September 4, 2026).
Clearance details
- Applicant
- Ortho Clinical Diagnostics Inc. (QuidelOrtho)
- Product code
- Product code PSZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3328
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- San Diego, CA, US
Recent devices under product code PSZ
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