OOU — Parainfluenza Multiplex Nucleic Acid Assay Class II

FDA Device Classification

Classification Details

Product Code
OOU
Device Class
Class II
Regulation Number
866.3980
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172282hologicPanther Fusion Paraflu AssayOctober 23, 2017
K153223hologicProParaFlu+ AssayDecember 9, 2015
K141927quidel corporationLYRA PARAINFLUENZA VIRUS ASSAYOctober 9, 2014
K132238gen-probe prodessePROPARAFLU+ ASSAYAugust 26, 2013
K091053prodessePROPARAFLU+ASSAYNovember 20, 2009