Cleared Traditional

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

K113433 · Focus Diagnostics, Inc. · Microbiology
Apr 2012
Decision
135d
Days
Class 1
Risk

About This 510(k) Submission

K113433 is an FDA 510(k) clearance for the SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT, a C. Difficile Nucleic Acid Amplification Test Assay (Class I — General Controls, product code OMN), submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on April 4, 2012, 135 days after receiving the submission on November 21, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K113433 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date April 04, 2012
Days to Decision 135 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.