510(k) K241188

Acucy® Influenza A&B Test with the Acucy® 2 System by SEKISUI Diagnostics, LLC — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 18, 2025
Date Received: April 29, 2024
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 by SEKISUI Diagnostics, LLC

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K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (June 22, 2018)
K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)

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)
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)
K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (March 20, 2018)