Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA— 510(k) K254262

Name: FDA 510(k) clearance K254262
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

Ortho 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.

Clearance details

Applicant: Ortho Clinical Diagnostics Inc. (QuidelOrtho)
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2025-12-30
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSZ

view all

K252283 — Nano-Check Influenza A+B Test2026-01-15
K250398 — Innovita Flu A/B Antigen Rapid Test2025-07-03
K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System2025-04-18
K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit2023-12-05
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit2023-01-27

More clearances from Ortho Clinical Diagnostics Inc. (QuidelOrtho)

view all

K254264 — Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA2026-09-04
K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA2026-07-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.