PEN · Class II · 21 CFR 866.3365

FDA Product Code PEN: Gram-negative Bacteria And Associated Resistance Markers

A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.

Leading manufacturers include Biofire Diagnostics, LLC, Genmark Diagnostics, Incorporated and Luminex Corporation.

11
Total
11
Cleared
108d
Avg days
2013
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 109d avg (recent)

FDA 510(k) Cleared Gram-negative Bacteria And Associated Resistance Markers Devices (Product Code PEN)

11 devices
1–11 of 11
Cleared Apr 18, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay
K243013
Luminex Corporation
Microbiology · 203d
Cleared Dec 20, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
K243759
Biofire Diagnostics, LLC
Microbiology · 14d
Cleared Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236
Genmark Diagnostics, Incorporated
Microbiology · 209d
Cleared Mar 18, 2020
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Jun 28, 2019
iC-GN iC-Cassette for use on the iC-System
K190341
Icubate, Inc.
Microbiology · 134d
Cleared Apr 12, 2019
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K182619
Genmark Diagnostics, Incorporated
Microbiology · 200d
Cleared Jul 05, 2018
FilmArray Blood Culture Identification (BCID) Panel
K181493
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457
Biofire Diagnostics, LLC
Microbiology · 25d
Cleared Jan 30, 2015
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
K143171
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843
Nanosphere, Inc.
Microbiology · 120d
Cleared Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914
Biofire Diagnostics, Inc.
Microbiology · 80d

About Product Code PEN - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code PEN since 2013, with 11 receiving FDA clearance (average review time: 108 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PEN Product Code

FDA review times for PEN submissions have been consistent, averaging 109 days recently vs 108 days historically.

PEN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →