Cleared Special

K160459 - FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

K160459 is an FDA 510(k) clearance for FilmArray Gastrointestinal Panel (GI) f..., manufactured by Biofire Diagnostics, LLC. The device is a Class 2 Microbiology device with product code PCH cleared through the Special 510(k) pathway after a 42-day FDA review.

K160459 · Biofire Diagnostics, LLC · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
42d
Days
Class 2
Risk

K160459 is an FDA 510(k) clearance for the FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch. Classified as Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (product code PCH), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on April 1, 2016 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3990 - 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 - K160459

510(k) Number K160459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date April 01, 2016
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

PCH Device Classification - Class 2, Special Controls

Product Code PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3990
Definition A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation 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.

Regulatory Peers - PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

All 37
Devices cleared under the same product code (PCH) and FDA review panel - the closest regulatory comparables to K160459.
BD MAX Enteric Viral Panel, BD MAX Instrument
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BioCode Gastrointestinal Pathogen Panel (GPP)
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BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · Becton, Dickinson and Company · May 2017
Great Basin Shiga Toxin Direct Test
K152955 · Great Basin Scientific, Inc. · Mar 2016
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · Becton, Dickinson and Company · Aug 2015
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
K143005 · Biofire Diagnostics, LLC · Feb 2015
K160459 · FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
Download PDF FDA Summary Biofire Diagnostics, …