Cleared Traditional

K170883 - FilmArray NGDS Warrior Panel (FDA 510(k) Clearance)

K170883 · Biofire Defense, LLC · Microbiology device
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Jun 2017
Decision
90d
Days
-
Risk

K170883 is an FDA 510(k) clearance for the FilmArray NGDS Warrior Panel.

Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Cleared decision on June 22, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K170883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2017
Decision Date June 22, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PRD
Device Class -