Cleared Special

K160457 - FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K160457 · Biofire Diagnostics, LLC · Microbiology device
Download Printable Device Report (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.

View all Biofire Diagnostics, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K160457.
LIAISON PLEX Gram-Negative Blood Culture Assay
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BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · Biofire Diagnostics, LLC · Mar 2020
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K182619 · Genmark Diagnostics, Incorporated · Apr 2019