510(k) K163626

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit by Luminex Corporation — Product Code OZZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 2, 2017
Date Received: December 22, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bordetella Pertussis Dna Assay System
Device Class: Class II
Regulation Number: 866.3980
Review Panel: MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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