Cleared Dual Track

Accula Flu A/Flu B Test

K171641 · Mesa Biotech, Inc. · Microbiology

Feb 2018

Decision

249d

Days

Class 2

Risk

About This 510(k) Submission

K171641 is an FDA 510(k) clearance for the Accula Flu A/Flu B Test, a Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OZE), submitted by Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 6, 2018, 249 days after receiving the submission on June 2, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K171641 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2017
Decision Date	February 06, 2018
Days to Decision	249 days
Submission Type	Dual Track
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.