Cleared Traditional

K080570 - CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL

K080570 is an FDA 510(k) clearance for CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-..., manufactured by Centers For Disease Control and Prevention. The device is a Class 2 Microbiology device with product code NXD cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K080570 · Centers For Disease Control and Prevention · Microbiology device
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Sep 2008
Decision
214d
Days
Class 2
Risk

K080570 is an FDA 510(k) clearance for the CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL. Classified as Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna (product code NXD), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on September 30, 2008 after a review of 214 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3332 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K080570

510(k) Number K080570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2008
Decision Date September 30, 2008
Days to Decision 214 days
Submission Type Traditional
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
112d slower than avg
Panel avg: 102d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXD Device Classification - Class 2, Special Controls

Product Code NXD Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3332
Definition Novel Influenza A Virus Reagents Are Used In Nucleic Acid Amplification Tests To Directly Detect And Differentiate Novel Influenza A Virus Specific Rna Gene Segments In Human Respiratory Specimens Or Viral Cultures. Detection And Differentiation Of Specific Rna Gene Segments Aids In The Diagnosis Of Influenza Caused By Novel Influenza A Viruses In Patients With Clinical And Epidemiological Risk Of Infection With These Viruses. They Also Aid In The Presumptive Identification Of Specific Novel Influenza A Viruses And Provide Epidemiological Information On Influenza. These Reagents Are Primers And Probes, Along With A Specific Novel Influenza Virus Control.
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.