Cleared Traditional

FILMARRAY GASTROINTESTINAL (GI) PANEL (K140407) - FDA 510(k) Clearance

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

K140407 · Biofire Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
73d
Days
Class 2
Risk

K140407 is an FDA 510(k) clearance for the FILMARRAY GASTROINTESTINAL (GI) PANEL. Classified as Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (product code PCH), Class II - Special Controls.

Submitted by Biofire Diagnostics (Salt Lake City, US). The FDA issued a Cleared decision on May 2, 2014 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biofire Diagnostics devices

Submission Details

510(k) Number K140407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date May 02, 2014
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (PCH) and FDA review panel - the closest regulatory comparables to K140407.
BioCode Gastrointestinal Pathogen Panel (GPP)
K180041 · Applied BioCode, Inc. · Sep 2018
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · Becton, Dickinson and Company · May 2017
BD MAX Enteric Parasite Panel, BD MAX Instrument
K143648 · Becton, Dickinson and Company · Aug 2015