Cleared Special

K160462 - FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

K160462 is an FDA 510(k) clearance for FilmArray Meningitis/Encephalitis (ME) ..., manufactured by Biofire Diagnostics, LLC. The device is a Class 2 Microbiology device with product code PLO cleared through the Special 510(k) pathway after a 27-day FDA review.

K160462 · Biofire Diagnostics, LLC · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
27d
Days
Class 2
Risk

K160462 is an FDA 510(k) clearance for the FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch. 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 Cleared decision on March 17, 2016 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3970 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K160462

510(k) Number K160462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date March 17, 2016
Days to Decision 27 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

PLO Device Classification - Class 2, Special Controls

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.

K160462 · FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
Download PDF FDA Summary Biofire Diagnostics, …