Cleared Traditional

K213236 - ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (FDA 510(k) Clearance)

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

K213236 · Genmark Diagnostics, Incorporated · Microbiology device
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Apr 2022
Decision
209d
Days
Class 2
Risk

K213236 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 27, 2022 after a review of 209 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

Submission Details

510(k) Number K213236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date April 27, 2022
Days to Decision 209 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
107d slower than avg
Panel avg: 102d · This submission: 209d
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 K213236.
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
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · Biofire Diagnostics, LLC · Mar 2020