Cleared Dual Track

K241188 - Acucy® Influenza A&B Test with the Acucy® 2 System (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K241188 · SEKISUI Diagnostics, LLC · Microbiology device
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Apr 2025
Decision
354d
Days
Class 2
Risk

K241188 is an FDA 510(k) clearance for the Acucy® Influenza A&B Test with the Acucy® 2 System. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on April 18, 2025 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all SEKISUI Diagnostics, LLC devices

Submission Details

510(k) Number K241188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2024
Decision Date April 18, 2025
Days to Decision 354 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 102d · This submission: 354d
Pathway characteristics

Device Classification

Product Code PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3328
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PSZ Devices Detecting Influenza A, B, And C Virus Antigens

All 71
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K241188.
Nano-Check Influenza A+B Test
K252283 · Nano-Ditech Corporation · Jan 2026
Innovita Flu A/B Antigen Rapid Test
K250398 · Innovita (Tangshan) Biological Technology Co., Ltd. · Jul 2025
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
K232434 · Bd · Dec 2023
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
K223016 · Bd · Jan 2023