Cleared Traditional

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

K163626 · Luminex Corporation · Microbiology

May 2017

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K163626 is an FDA 510(k) clearance for the ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit, a Bordetella Pertussis Dna Assay System (Class II — Special Controls, product code OZZ), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on May 2, 2017, 131 days after receiving the submission on December 22, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K163626 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2016
Decision Date	May 02, 2017
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZZ — Bordetella Pertussis Dna Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	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.