Not Cleared Post-NSE

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

DEN060008 is an FDA 510(k) submission for INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS ..., manufactured by Centers For Disease Control and Prevention. The device is a Class 2 Microbiology device with product code NXD cleared through the Post-NSE 510(k) pathway after a 7-day FDA review.

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.

FDA 510(k) Submission Details - DEN060008

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

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.

DEN060008 · INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
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