Cleared Special

K140851 - INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (FDA 510(k) Clearance)

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

K140851 · Centers For Disease Control and Prevention · Microbiology device
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Apr 2014
Decision
22d
Days
Class 2
Risk

K140851 is an FDA 510(k) clearance for the INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOS.... Classified as Influenza A Virus Subtype Differentiation Nucleic Acid Assay (product code OEP), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on April 25, 2014 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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 K140851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2014
Decision Date April 25, 2014
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OEP Influenza A Virus Subtype Differentiation Nucleic Acid Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Qualitative In Vitro Diagnostic Assay Intended To Detect And Differentiate Between Influenza A Virus Subtypes In Human Respiratory Specimens Or Viral Culture. Detection And Differentiation Of Specific Subtype Rna Aids In The Diagnosis Of Influenza Caused By Influenza A In Conjunction With Other Clinical And Laboratory Testing In Patients Suspected Of Being Infected With These Viruses. Also, It Aids In The Presumptive Laboratory Identification Of Influenza A Virus Subtypes To Provide Epidemiological Information On Influenza.
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.