Cleared Traditional

K143171 - FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0

K143171 is an FDA 510(k) clearance for FilmArray Blood Culture Identification ..., manufactured by Biofire Diagnostics, LLC. The device is a Class 2 Microbiology device with product code PEN cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K143171 · Biofire Diagnostics, LLC · Microbiology device
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Jan 2015
Decision
87d
Days
Class 2
Risk

K143171 is an FDA 510(k) clearance for the FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArra.... Classified as Gram-negative Bacteria And Associated Resistance Markers (product code PEN), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on January 30, 2015 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3365 - 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, LLC devices

FDA 510(k) Submission Details - K143171

510(k) Number K143171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2014
Decision Date January 30, 2015
Days to Decision 87 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEN Device Classification - Class 2, Special Controls

Product Code PEN Gram-negative Bacteria And Associated Resistance Markers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3365
Definition A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.
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 - PEN Gram-negative Bacteria And Associated Resistance Markers

All 10
Devices cleared under the same product code (PEN) and FDA review panel - the closest regulatory comparables to K143171.
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K182619 · Genmark Diagnostics, Incorporated · Apr 2019
FilmArray Blood Culture Identification (BCID) Panel
K181493 · Biofire Diagnostics, LLC · Jul 2018
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · Biofire Diagnostics, LLC · Mar 2016
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843 · Nanosphere, Inc. · Jan 2014
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914 · Biofire Diagnostics, Inc. · Jun 2013