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510(k) K254262

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA by Ortho Clinical Diagnostics Inc. (QuidelOrtho) — Product Code PSZ

K254262 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics Inc. (QuidelOrtho) for the device "Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA". The FDA issued a decision of Substantially Equivalent on September 4, 2026. The device falls under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens), a Class II device regulated under 21 CFR 866.3328.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2026
Date Received
December 30, 2025
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices Detecting Influenza A, B, And C Virus Antigens
Device Class
Class II
Regulation Number
866.3328
Review Panel
MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other clearances for product code PSZ

  • K252283 — Nano-Check Influenza A+B Test (January 15, 2026)
  • K250398 — Innovita Flu A/B Antigen Rapid Test (July 3, 2025)
  • K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System (April 18, 2025)
  • K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
  • K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
  • K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
  • K191514 — CareStart Flu A&B Plus (February 18, 2020)
  • K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
  • K182157 — BioSign Flu A+B (September 18, 2018)
  • K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)

FDA data resources