Cleared Traditional

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

K213236 · Genmark Diagnostics, Incorporated · Microbiology

Apr 2022

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K213236 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, a Gram-negative Bacteria And Associated Resistance Markers (Class II — Special Controls, product code PEN), submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on April 27, 2022, 209 days after receiving the submission on September 30, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K213236 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PEN — Gram-negative Bacteria And Associated Resistance Markers
Device Class	Class II — 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.