Cleared Special

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K123905) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K123905 · Centers For Disease Control and Prevention · Microbiology device
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Jan 2013
Decision
26d
Days
Class 2
Risk

K123905 is an FDA 510(k) clearance for the CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL. Classified as 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (product code OQW), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on January 14, 2013 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3332 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K123905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date January 14, 2013
Days to Decision 26 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OQW 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3332
Definition 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.