Not Cleared Post-NSE

DEN060008 - INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN060008 · Centers For Disease Control and Prevention · Microbiology device
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Feb 2006
Decision
7d
Days
Class 2
Risk

DEN060008 is an FDA 510(k) submission (not cleared) for the INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET. 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 Not Cleared (DENG) decision on February 3, 2006 after a review of 7 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

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Submission Details

510(k) Number DEN060008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 27, 2006
Decision Date February 03, 2006
Days to Decision 7 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 102d · This submission: 7d
Pathway characteristics

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.