Cleared Traditional

K042472 - BD DIRECTIGEN EZ FLU A + B (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042472 · Becton, Dickinson & CO · Microbiology device
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Jul 2005
Decision
300d
Days
Class 2
Risk

K042472 is an FDA 510(k) clearance for the BD DIRECTIGEN EZ FLU A + B. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (San Diego, US). The FDA issued a Cleared decision on July 7, 2005 after a review of 300 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K042472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2004
Decision Date July 07, 2005
Days to Decision 300 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 102d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K042472.
Nano-Check Influenza A+B Test
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Innovita Flu A/B Antigen Rapid Test
K250398 · Innovita (Tangshan) Biological Technology Co., Ltd. · Jul 2025
Acucy® Influenza A&B Test with the Acucy® 2 System
K241188 · SEKISUI Diagnostics, LLC · Apr 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