Cleared Traditional

K182619 - ePlex Blood Culture Identification Gram...

K182619 is an FDA 510(k) clearance for ePlex Blood Culture Identification Gram..., manufactured by Genmark Diagnostics, Incorporated. The device is a Class 2 Microbiology device with product code PEN cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K182619 · Genmark Diagnostics, Incorporated · Microbiology device
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Apr 2019
Decision
200d
Days
Class 2
Risk

K182619 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel. Classified as Gram-negative Bacteria And Associated Resistance Markers (product code PEN), Class II - Special Controls.

Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on April 12, 2019 after a review of 200 days - an extended review 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: 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 Genmark Diagnostics, Incorporated devices

FDA 510(k) Submission Details - K182619

510(k) Number K182619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date April 12, 2019
Days to Decision 200 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
98d slower than avg
Panel avg: 102d · This submission: 200d
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 8
Devices cleared under the same product code (PEN) and FDA review panel - the closest regulatory comparables to K182619.
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236 · Genmark Diagnostics, Incorporated · Apr 2022
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · Biofire Diagnostics, LLC · Mar 2020
iC-GN iC-Cassette for use on the iC-System
K190341 · Icubate, Inc. · Jun 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
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
K143171 · Biofire Diagnostics, LLC · Jan 2015