Cleared Traditional

K053146 - QUICKVUE INFLUENZA A + B TEST

K053146 is the FDA 510(k) clearance for QUICKVUE INFLUENZA A + B TEST by Quidel Corp.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K053146 · Quidel Corp. · Microbiology device
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Dec 2005
Decision
34d
Days
Class 2
Risk

K053146 is an FDA 510(k) clearance for the QUICKVUE INFLUENZA A + B TEST. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on December 14, 2005 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quidel Corp. devices

Submission Details

510(k) Number K053146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2005
Decision Date December 14, 2005
Days to Decision 34 days
Submission Type Traditional
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
68d faster than avg
Panel avg: 102d · This submission: 34d
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 43
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K053146.
XPECT FLU A & B
K092423 · Thermo Fisher Scientific · Aug 2009
SAS INFLUENZA A & B TEST
K080380 · Sa Scientific, Inc. · Jul 2009
BD DIRECTIGEN EZ FLU A+B TEST
K063689 · Becton, Dickinson & CO · Mar 2007
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