Cleared Traditional

XPERT C. DIFFICLE/EPI ASSAY

K110203 · Cepheid · Microbiology

Apr 2011

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K110203 is an FDA 510(k) clearance for the XPERT C. DIFFICLE/EPI ASSAY, a C. Difficile Nucleic Acid Amplification Test Assay (Class I — General Controls, product code OMN), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 7, 2011, 73 days after receiving the submission on January 24, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K110203 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2011
Decision Date	April 07, 2011
Days to Decision	73 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.