Cleared Special

K160457 - FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

K160457 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 Special 510(k) pathway after a 25-day FDA review.

K160457 · 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
25d
Days
Class 2
Risk

K160457 is an FDA 510(k) clearance for the FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch. 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 March 15, 2016 after a review of 25 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. 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 - K160457

510(k) Number K160457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date March 15, 2016
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 11
Devices cleared under the same product code (PEN) and FDA review panel - the closest regulatory comparables to K160457.
iC-GN iC-Cassette for use on the iC-System
K190341 · Icubate, Inc. · Jun 2019
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 the FilmArray 2.0
K143171 · Biofire Diagnostics, LLC · Jan 2015
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
K160457 · FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
Download PDF FDA Summary Biofire Diagnostics, …