Cleared Special

K151291 - BD Veritor (TM) System for the Rapid De...

K151291 is an FDA 510(k) clearance for BD Veritor (TM) System for the Rapid De..., manufactured by Becton, Dickinson and Company. The device is a Class 2 Microbiology device with product code PSZ cleared through the Special 510(k) pathway after a 26-day FDA review.

K151291 · Becton, Dickinson and Company · Microbiology device
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Jun 2015
Decision
26d
Days
Class 2
Risk

K151291 is an FDA 510(k) clearance for the BD Veritor (TM) System for the Rapid Detection of 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 and Company (San Diego, US). The FDA issued a Cleared decision on June 10, 2015 after a review of 26 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K151291

510(k) Number K151291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2015
Decision Date June 10, 2015
Days to Decision 26 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
76d faster than avg
Panel avg: 102d · This submission: 26d
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 57
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K151291.
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · Becton, Dickinson & CO · Feb 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · Becton, Dickinson & CO · Feb 2016
Sofia Influenza A+B FIA
K153012 · Quidel Corporation · Jan 2016
BD Veritor™ System Flu A+B Assay
K151301 · Becton, Dickinson and Company · Jun 2015
TRU FLU
K133714 · Meridian Bioscience, Inc. · Jan 2014
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · Princeton BioMeditech Corp. · Dec 2013