Cleared Traditional

BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) - FDA 510(k) Clearance

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

K193519 · Biofire Diagnostics, LLC · Microbiology device
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Mar 2020
Decision
90d
Days
Class 2
Risk

K193519 is an FDA 510(k) clearance for the BioFire Blood Culture Identification 2 (BCID2) Panel. 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 18, 2020 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biofire Diagnostics, LLC devices

Submission Details

510(k) Number K193519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2019
Decision Date March 18, 2020
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K193519.
LIAISON PLEX Gram-Negative Blood Culture Assay
K243013 · Luminex Corporation · Apr 2025
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
K243759 · Biofire Diagnostics, LLC · Dec 2024
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236 · Genmark Diagnostics, Incorporated · Apr 2022
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