Not Cleared Direct

DEN160048 - FilmArray NGDS Warrior Panel (FDA 510(k) Clearance)

DEN160048 · Biofire Defense, LLC · Microbiology device
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Feb 2017
Decision
120d
Days
-
Risk

DEN160048 is an FDA 510(k) submission (not cleared) for the FilmArray NGDS Warrior Panel.

Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on February 14, 2017 after a review of 120 days.

This device falls under the Microbiology FDA review panel. 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 DEN160048 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 17, 2016
Decision Date February 14, 2017
Days to Decision 120 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 102d · This submission: 120d
Pathway characteristics

Device Classification

Product Code PRD
Device Class -