Cleared Special

K092698 - QUICKVUE INFLUENZA A+B TEST

K092698 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 Special 510(k) pathway after a 13-day FDA review.

K092698 · Quidel Corp. · Microbiology device
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Sep 2009
Decision
13d
Days
Class 2
Risk

K092698 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 September 15, 2009 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quidel Corp. devices

Submission Details

510(k) Number K092698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2009
Decision Date September 15, 2009
Days to Decision 13 days
Submission Type Special
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
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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 K092698.
BD DIRECTIGEN EX FLU A+B
K101461 · Becton, Dickinson and Company · Jun 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · Becton, Dickinson & CO · Jun 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · Sa Scientific, Inc. · Feb 2010
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