Cleared Special

K140851 - INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

K140851 is an FDA 510(k) clearance for INFLUENZA A SUBTYPING KIT, manufactured by Centers For Disease Control and Prevention. The device is a Class 2 Microbiology device with product code OEP cleared through the Special 510(k) pathway after a 22-day FDA review.

K140851 · Centers For Disease Control and Prevention · Microbiology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

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.

FDA 510(k) Submission Details - K140851

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

80d faster than avg

Panel avg: 102d · This submission: 22d

Pathway characteristics

Modification to existing cleared device.

OEP Device Classification - Class 2, Special Controls

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.

FDA 510(k) Resources - Microbiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.