Cleared Traditional

K041049 - BINAXNOW INFLUENZA A & B TEST

K041049 is the FDA 510(k) clearance for BINAXNOW INFLUENZA A & B TEST by Binax, Inc.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K041049 · Binax, Inc. · Microbiology device
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Aug 2004
Decision
110d
Days
Class 2
Risk

K041049 is an FDA 510(k) clearance for the BINAXNOW INFLUENZA A & B TEST. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on August 10, 2004 after a review of 110 days - within the typical 510(k) review window.

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.

View all Binax, Inc. devices

Submission Details

510(k) Number K041049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date August 10, 2004
Days to Decision 110 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
8d slower than avg
Panel avg: 102d · This submission: 110d
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 44
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K041049.
BD DIRECTIGEN EZ FLU A+B TEST
K063689 · Becton, Dickinson & CO · Mar 2007
QUICKVUE INFLUENZA A + B TEST
K053146 · Quidel Corp. · Dec 2005
BD DIRECTIGEN EZ FLU A + B
K042472 · Becton, Dickinson & CO · Jul 2005
SAS INFLUENZA B TEST
K041439 · Sa Scientific, Inc. · Jul 2004
SAS INFLUENZA A TEST
K041441 · Sa Scientific, Inc. · Jul 2004
QUICKVUE INFLUENZA A+B TEST
K031899 · Quidel Corp. · Sep 2003