Cleared Traditional

K163626 - ARIES Bordetella Assay

Also marketed or referenced as:
ARIES Bordetella Assay Protocol File Kit

K163626 is an FDA 510(k) clearance for ARIES Bordetella Assay, manufactured by Luminex Corporation. The device is a Class 2 Microbiology device with product code OZZ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K163626 · Luminex Corporation · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
131d
Days
Class 2
Risk

K163626 is an FDA 510(k) clearance for the ARIES Bordetella Assay. Classified as Bordetella Pertussis Dna Assay System (product code OZZ), Class II - Special Controls.

Submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on May 2, 2017 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163626

510(k) Number K163626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 102d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

OZZ Device Classification - Class 2, Special Controls

Product Code OZZ Bordetella Pertussis Dna Assay System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02862262 Completed Interventional Industry-sponsored

A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients

1052
Patients (actual)
6
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Bordetella Infections; Bordetella Pertussis Infection; Bordetella Parapertussis Infection
Study design Parallel
Eligibility All sexes
Principal investigator Ronald Dunn
Sponsor Luminex Molecular Diagnostics (industry)
Started 2016-07-01 → Primary completion 2016-11-01 → Completed 2016-11-14
Primary outcome
Specificity and sensitivity of the ARIES Bordetella Assay in patients suspected of having respiratory infection attributable to B. pertussis or B. parapertussis.
Secondary outcome
Clinical performance of the ARIES Bordetella Assay per clinical site.
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - OZZ Bordetella Pertussis Dna Assay System

All 8
Devices cleared under the same product code (OZZ) and FDA review panel - the closest regulatory comparables to K163626.
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K183223 · Diasorin Molecular, LLC · Dec 2018
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K173498 · Diasorin Molecular, LLC · Aug 2018
Solana Bordetella Complete Assay
K181029 · Quidel Corporation · Jul 2018
Great Basin Bordetella Direct Test
K170284 · Great Basin Scientific, Inc. · Mar 2017
illumigene Pertussis DNA Amplification Assay
K152285 · Meridian Bioscience, Inc. · Nov 2015
AmpliVue Bordetella Assay
K143206 · Quidel Corporation · Dec 2014
K163626 · ARIES Bordetella Assay
Download PDF FDA Summary Luminex Corporation