Cleared Special

ProParaFlu+ Assay

K153223 · Hologic, Inc. · Microbiology
Dec 2015
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K153223 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 Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on December 9, 2015, 33 days after receiving the submission on November 6, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K153223 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2015
Decision Date December 09, 2015
Days to Decision 33 days
Submission Type Special
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.