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510(k) K241188

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

K241188 is an FDA 510(k) premarket notification submitted by SEKISUI Diagnostics, LLC for the device "Acucy® Influenza A&B Test with the Acucy® 2 System". The FDA issued a decision of Substantially Equivalent on April 18, 2025. 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. SEKISUI Diagnostics, LLC has at least 5 other 510(k) clearances on record.

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

  • K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
  • 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)

FDA data resources