Cleared Traditional

PROPARAFLU+ASSAY

K091053 · Prodesse, Inc. · Microbiology
Nov 2009
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K091053 is an FDA 510(k) clearance for the PROPARAFLU+ASSAY, a Parainfluenza Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OOU), submitted by Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 20, 2009, 221 days after receiving the submission on April 13, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K091053 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2009
Decision Date November 20, 2009
Days to Decision 221 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OOU — Parainfluenza Multiplex Nucleic Acid Assay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Parainfluenza Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Parainfluenza 1 Virus, Parainfluenza 2 Virus, Parainfluenza 3 Virus And Parainfluenza 4 Virus 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 Human Parainfluenza Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Parainfluenza Infections If Used In Conjunction With Other Clinical And Laboratory Findings.