Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

FDA 510(k) K254262 · Ortho Clinical Diagnostics Inc. (QuidelOrtho)

Substantially Equivalent

510(k) numberK254262

Submission

Device name
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Applicant
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
San Diego, CA, US
Received
December 30, 2025
Decision date
September 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Dual Track 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PSZ – Devices Detecting Influenza A, B, And C Virus Antigens
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3328
Specialty
Microbiology

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 510(k)s with product code PSZ

510(k)DeviceApplicantDecision
K252283Nano-Check Influenza A+B TestPSZ · Dual Track Nano-Ditech Corporation01/15/2026SE
K250398Innovita Flu A/B Antigen Rapid TestPSZ · Traditional Innovita (Tangshan) Biological Technology Co.…07/03/2025SE
K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ · Dual Track SEKISUI Diagnostics, LLC04/18/2025SE
K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitPSZ · Traditional Bd12/05/2023SE
K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ · Traditional Bd01/27/2023SE
K192719Osom Ultra Plus Flu A&B Test KitPSZ · Dual Track SEKISUI Diagnostics, LLC04/03/2020SE
K191514CareStart Flu A&B PlusPSZ · Dual Track Access Bio, Inc.02/18/2020SE
K182001Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track SEKISUI Diagnostics, LLC12/17/2018SE
K182157BioSign Flu A+BPSZ · Special Princeton BioMeditech Corp.09/18/2018SE
K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderPSZ · Special Alere Scarborough, Inc.08/08/2018SE

More from Alere Scarborough, Inc.

510(k)DeviceDecision
K254264Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track 09/04/2026SE
K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIALSR · Traditional 07/10/2026SE

Questions and answers

When was Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA cleared by the FDA?

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA (K254262) received a 510(k) decision of Substantially Equivalent on September 4, 2026, 248 days after the submission was received.

What is the product code of K254262?

The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.