Cleared Special

K161556 - CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

K161556 is an FDA 510(k) clearance for CDC Human Influenza Virus Real-time RT-..., manufactured by Centers For Disease Control and Prevention (Cdc). The device is a Class 2 Microbiology device with product code OZE cleared through the Special 510(k) pathway after a 24-day FDA review.

K161556 · Centers For Disease Control and Prevention (Cdc) · Microbiology device
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Jun 2016
Decision
24d
Days
Class 2
Risk

K161556 is an FDA 510(k) clearance for the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subt.... Classified as Influenza A And Influenza B Multiplex Nucleic Acid Assay (product code OZE), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Cdc) (Atlanta, US). The FDA issued a Cleared decision on June 30, 2016 after a review of 24 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.

View all Centers For Disease Control and Prevention (Cdc) devices

FDA 510(k) Submission Details - K161556

510(k) Number K161556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2016
Decision Date June 30, 2016
Days to Decision 24 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
78d faster than avg
Panel avg: 102d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

OZE Device Classification - Class 2, Special Controls

Product Code OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition An Influenza A And Influenza B Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Influenza A And Influenza B Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Influenza A And B Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Influenza Viral Infections If Used In Conjunction With Other Clinical And Laboratory Findings.
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.

Regulatory Peers - OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

All 19
Devices cleared under the same product code (OZE) and FDA review panel - the closest regulatory comparables to K161556.
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
K181736 · Centers For Disease Control and Prevention (Cdc) · Jul 2018
Accula Flu A/Flu B Test
K171641 · Mesa Biotech, Inc. · Feb 2018
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
K172091 · Centers For Disease Control and Prevention · Aug 2017
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
K153148 · Centers For Disease Control and Prevention (Cdc) · Dec 2015
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
K141859 · Centers For Disease Control and Prevention · Aug 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K140857 · Centers For Disease Control and Prevention · Apr 2014