Cleared Traditional

PROFLU+ ASSAY

K073029 · Prodesse, Inc. · Microbiology

Jan 2008

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K073029 is an FDA 510(k) clearance for the PROFLU+ ASSAY, a Respiratory Virus Panel Nucleic Acid Assay System (Class II — Special Controls, product code OCC), submitted by Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on January 4, 2008, 67 days after receiving the submission on October 29, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K073029 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2007
Decision Date	January 04, 2008
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OCC — Respiratory Virus Panel Nucleic Acid Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.