Not Cleared Post-NSE

DEN070013 - ID-TAG RESPIRATORY VIRAL PANEL (FDA 510(k) Clearance)

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

DEN070013 · Luminex Molecular Diagnostics, Inc. · Microbiology device
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Jan 2008
Decision
30d
Days
Class 2
Risk

DEN070013 is an FDA 510(k) submission (not cleared) for the ID-TAG RESPIRATORY VIRAL PANEL. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Luminex Molecular Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Not Cleared (DENG) decision on January 3, 2008 after a review of 30 days.

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 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.

View all Luminex Molecular Diagnostics, Inc. devices

Submission Details

510(k) Number DEN070013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 04, 2007
Decision Date January 03, 2008
Days to Decision 30 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
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics

Device Classification

Product Code OCC Respiratory Virus Panel Nucleic Acid Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.
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 - OCC Respiratory Virus Panel Nucleic Acid Assay System

All 78
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