Cleared Special

K132465 - BIOSIGN FLU A + B, STATUS FLU A & B

K132465 is an FDA 510(k) clearance for BIOSIGN FLU A + B, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Microbiology device with product code PSZ cleared through the Special 510(k) pathway after a 33-day FDA review.

K132465 · Princeton BioMeditech Corp. · Microbiology device
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Sep 2013
Decision
33d
Days
Class 2
Risk

K132465 is an FDA 510(k) clearance for the BIOSIGN FLU A + B, STATUS FLU A & B. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on September 9, 2013 after a review of 33 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 - K132465

510(k) Number K132465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date September 09, 2013
Days to Decision 33 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 102d · This submission: 33d
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 K132465.
BD Veritor™ System Flu A+B Assay
K133138 · Becton, Dickinson & CO · Nov 2013
BD Veritor™ System Flu A+B Assay
K132693 · Becton, Dickinson and Company · Oct 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · Becton, Dickinson and Company · Sep 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · Becton, Dickinson and Company · Aug 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · Becton, Dickinson and Company · Aug 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797 · Becton, Dickinson and Company · Sep 2012
K132465 · BIOSIGN FLU A + B, STATUS FLU A & B
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