Not Cleared Direct

DEN170017 - FilmArray Respiratory Panel 2 plus (RP2plus) (FDA 510(k) Clearance)

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

DEN170017 · Biofire Diagnostics, LLC · Microbiology device
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Nov 2017
Decision
253d
Days
Class 2
Risk

DEN170017 is an FDA 510(k) submission (not cleared) for the FilmArray Respiratory Panel 2 plus (RP2plus). Classified as Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System (product code PZF), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on November 24, 2017 after a review of 253 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.4001 - 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: Regulatory edge-case submission. Elevated predicate reliance profile. With 253 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN170017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 16, 2017
Decision Date November 24, 2017
Days to Decision 253 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 102d · This submission: 253d
Pathway characteristics

Device Classification

Product Code PZF Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4001
Definition A Middle East Respiratory Syndrome Coronavirus (mers-cov) And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Detection And Identification Of Mers-cov And Common Respiratory Pathogens – Associated Nucleic Acids In Human Clinical Specimens. The Test Is Indicated For Individuals Meeting Specific Mers-cov Clinical And/or Epidemiological Criteria. It Aids In The Differential Diagnosis Of Mers-cov Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data, In Accordance With The Guidelines Provided By The Appropriate Public Health Authorities.
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.