Cleared Traditional

ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA

K133673 · Meridian Bioscience, Inc. · Microbiology

Mar 2014

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K133673 is an FDA 510(k) clearance for the ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA, 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 March 25, 2014, 116 days after receiving the submission on November 29, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K133673 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2013
Decision Date	March 25, 2014
Days to Decision	116 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.