Cleared Traditional

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL (K080570) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080570 · Centers For Disease Control and Prevention · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Centers For Disease Control and Prevention devices

Submission Details

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
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.

Device Classification

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.