Cleared Traditional

ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10

K110012 · Meridian Bioscience, Inc. · Microbiology

Feb 2011

Decision

52d

Days

Class 1

Risk

About This 510(k) Submission

K110012 is an FDA 510(k) clearance for the ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10, a C. Difficile Nucleic Acid Amplification Test Assay (Class I — General Controls, product code OMN), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 24, 2011, 52 days after receiving the submission on January 3, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K110012 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2011
Decision Date	February 24, 2011
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OMN — C. Difficile Nucleic Acid Amplification Test Assay
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.2660
Definition	In Vitro Diagnostic Test For The Qualitative Detection Of Toxigenic Clostridium Difficile Nucleic Acids Isolated And Purified From Stool Specimens Obtained From Symptomatic Patients.