Cleared Traditional

K180966 - FilmArray Pneumonia Panel (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180966 · Biofire Diagnostics, LLC · Microbiology device
Nov 2018
Decision
210d
Days
Class 2
Risk

K180966 is an FDA 510(k) clearance for the FilmArray Pneumonia Panel. Classified as Respiratory Panel (product code QDP), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on November 9, 2018 after a review of 210 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3985 - the FDA microbiology device framework. 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.

Submission Details

510(k) Number K180966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date November 09, 2018
Days to Decision 210 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 174d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDP Respiratory Panel
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3985
Definition The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With Systems For The Simultaneous Detection And Identification Of Multiple Respiratory Viral And Bacterial Nucleic Acids, As Well As Select Antimicrobial Resistance Genes, In Sputum-like Specimens (induced Or Expectorated Sputum, Or Endotracheal Aspirates) Or Bronchoalveolar Lavage (bal)-like Specimens (bal Or Mini-bal) Obtained From Individuals Suspected Of Lower Respiratory Tract Infection.
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.