Cleared Traditional

illumigene Pertussis DNA Amplification Assay

K152285 · Meridian Bioscience, Inc. · Microbiology

Nov 2015

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K152285 is an FDA 510(k) clearance for the illumigene Pertussis DNA Amplification Assay, a Bordetella Pertussis Dna Assay System (Class II — Special Controls, product code OZZ), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 10, 2015, 90 days after receiving the submission on August 12, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K152285 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2015
Decision Date	November 10, 2015
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

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.