Cleared Traditional

FluChip-8G Influenza A+B Assay

K182513 · Indevr, Inc. · Microbiology

Apr 2019

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K182513 is an FDA 510(k) clearance for the FluChip-8G Influenza A+B Assay, a Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OZE), submitted by Indevr, Inc. (Boulder, US). The FDA issued a Cleared decision on April 22, 2019, 222 days after receiving the submission on September 12, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K182513 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2018
Decision Date	April 22, 2019
Days to Decision	222 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.