Cleared Traditional

K132508 - CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-...

K132508 is the FDA 510(k) clearance for CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-... by Centers For Disease Control and Prevention. It is a Class 2 Microbiology device (product code OZE) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K132508 · Centers For Disease Control and Prevention · Microbiology device
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Sep 2013
Decision
42d
Days
Class 2
Risk

K132508 is an FDA 510(k) clearance for the CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL. 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 (Atlanta, US). The FDA issued a Cleared decision on September 23, 2013 after a review of 42 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K132508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date September 23, 2013
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (OZE) and FDA review panel - the closest regulatory comparables to K132508.
ID NOW Influenza A & B 2
K190204 · Alere Scarborough, Inc. · Mar 2019
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
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · Quidel Corp. · Aug 2013
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · Quidel Corp. · Mar 2012