Cleared Special

K133714 - TRU FLU

K133714 is the FDA 510(k) clearance for TRU FLU by Meridian Bioscience, Inc.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K133714 · Meridian Bioscience, Inc. · Microbiology device
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Jan 2014
Decision
29d
Days
Class 2
Risk

K133714 is an FDA 510(k) clearance for the TRU FLU. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 3, 2014 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 Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K133714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2013
Decision Date January 03, 2014
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 44
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K133714.
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