Cleared Special

K153148 - CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

K153148 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 32-day FDA review.

K153148 · Centers For Disease Control and Prevention (Cdc) · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
32d
Days
Class 2
Risk

K153148 is an FDA 510(k) clearance for the CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 .... 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 December 1, 2015 after a review of 32 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 - K153148

510(k) Number K153148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date December 01, 2015
Days to Decision 32 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
70d faster than avg
Panel avg: 102d · This submission: 32d
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 20
Devices cleared under the same product code (OZE) and FDA review panel - the closest regulatory comparables to K153148.
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 Subtyping Kit
K161556 · Centers For Disease Control and Prevention (Cdc) · Jun 2016
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
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT
K133869 · Center For Disease Control and Prevention (Cdc) · Jan 2014
K153148 · CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
Download PDF FDA Summary Centers For Disease C…