Cleared Traditional

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

K123197 · Nanosphere, Inc. · Microbiology

Dec 2012

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K123197 is an FDA 510(k) clearance for the VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF), a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 5, 2012, 55 days after receiving the submission on October 11, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K123197 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2012
Decision Date	December 05, 2012
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3130
Definition	Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.