Cleared Traditional

ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

K100818 · Meridian Bioscience, Inc. · Microbiology
Jul 2010
Decision
108d
Days
Class 1
Risk

About This 510(k) Submission

K100818 is an FDA 510(k) clearance for the ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920, 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 July 9, 2010, 108 days after receiving the submission on March 23, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K100818 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2010
Decision Date July 09, 2010
Days to Decision 108 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.