Cleared Special

BD DIRECTIGEN EX FLU A+B (K101461) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101461 · Becton, Dickinson and Company · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
29d
Days
Class 2
Risk

K101461 is an FDA 510(k) clearance for the BD DIRECTIGEN EX 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 (La Jolla, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 29 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

Submission Details

510(k) Number K101461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2010
Decision Date June 24, 2010
Days to Decision 29 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
73d faster than avg
Panel avg: 102d · This submission: 29d
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 34
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K101461.
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797 · Becton, Dickinson and Company · Sep 2012
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K120049 · Becton, Dickinson and Company · Mar 2012
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277 · Becton, Dickinson and Company · Oct 2011
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
SAS INFLUENZA A & B TEST
K080380 · Sa Scientific, Inc. · Jul 2009