Cleared Traditional

K113433 - SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (FDA 510(k) Clearance)

Class I Microbiology device.

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

K113433 is an FDA 510(k) clearance for the SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT. Classified as C. Difficile Nucleic Acid Amplification Test Assay (product code OMN), Class I - General Controls.

Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on April 4, 2012 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Focus Diagnostics, Inc. devices

Submission Details

510(k) Number K113433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 102d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OMN C. Difficile Nucleic Acid Amplification Test Assay
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.