Cleared Traditional

QUIDEL MOLECULAR INFLUENZA A + B ASSAY

K131728 · Quidel Corp. · Microbiology

Aug 2013

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K131728 is an FDA 510(k) clearance for the QUIDEL MOLECULAR INFLUENZA A + B ASSAY, a Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OZE), submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 29, 2013, 78 days after receiving the submission on June 12, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K131728 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2013
Decision Date	August 29, 2013
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZE — Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	An Influenza A And Influenza B Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Influenza A And Influenza B Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Influenza A And B Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Influenza Viral Infections If Used In Conjunction With Other Clinical And Laboratory Findings.