510(k) K132238

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 26, 2013

Date Received

July 18, 2013

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Parainfluenza Multiplex Nucleic Acid Assay

Device Class

Class II

Regulation Number

866.3980

Review Panel

MI

Submission Type

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.