Not Cleared Direct

DEN150013 - FilmArray Meningitis/Encephalitis(ME) Panel (FDA 510(k) Clearance)

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

DEN150013 · Biofire Diagnostics, LLC · Microbiology device
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Oct 2015
Decision
182d
Days
Class 2
Risk

DEN150013 is an FDA 510(k) submission (not cleared) for the FilmArray Meningitis/Encephalitis(ME) Panel. Classified as Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (product code PLO), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on October 8, 2015 after a review of 182 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3970 - 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 DEN150013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 09, 2015
Decision Date October 08, 2015
Days to Decision 182 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics

Device Classification

Product Code PLO Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3970
Definition A Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Direct Detection And Identification Of Microbial-associated Nucleic Acids In Cerebrospinal Fluid. The Test Is Indicated For Individuals With Signs And Symptoms Of Meningitis Or Encephalitis And Aids In Diagnosis Of Agents Of Meningitis Or Encephalitis When Used In Conjunction With Clinical And Other Laboratory Findings.
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.