Cleared Special

TRU FLU

K133714 · Meridian Bioscience, Inc. · Microbiology

Jan 2014

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K133714 is an FDA 510(k) clearance for the TRU FLU, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 3, 2014, 29 days after receiving the submission on December 5, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K133714 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — 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.