Cleared Special

K180288 - QuickVue Influenza A+B

K180288 is an FDA 510(k) clearance for QuickVue Influenza A+B, manufactured by Quidel Corporation. The device is a Class 2 Microbiology device with product code PSZ cleared through the Special 510(k) pathway after a 12-day FDA review.

K180288 · Quidel Corporation · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
12d
Days
Class 2
Risk

K180288 is an FDA 510(k) clearance for the QuickVue Influenza A+B. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on February 13, 2018 after a review of 12 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.

FDA 510(k) Submission Details - K180288

510(k) Number K180288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2018
Decision Date February 13, 2018
Days to Decision 12 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
90d faster than avg
Panel avg: 102d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

PSZ Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K180288.
BioSign Flu A+B
K182157 · Princeton BioMeditech Corp. · Sep 2018
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
K181853 · Alere Scarborough, Inc. · Aug 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K180438 · Bd · Mar 2018
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
K173502 · Alere Scarborough, Inc. · Dec 2017
Sofia Influenza A+B FIA on Sofia 2
K162438 · Quidel Corporation · Apr 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
K162642 · Alere Scarborough, Inc. · Apr 2017
K180288 · QuickVue Influenza A+B
Download PDF FDA Summary Quidel Corporation