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510(k) K213236

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel by Genmark Diagnostics, Incorporated — Product Code PEN

K213236 is an FDA 510(k) premarket notification submitted by Genmark Diagnostics, Incorporated for the device "ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel". The FDA issued a decision of Substantially Equivalent on April 27, 2022. The device falls under product code PEN (Gram-Negative Bacteria And Associated Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Genmark Diagnostics, Incorporated has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2022
Date Received
September 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram-Negative Bacteria And Associated Resistance Markers
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

Other clearances by Genmark Diagnostics, Incorporated

  • K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 12, 2019)
  • K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (December 21, 2018)
  • K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (December 20, 2018)
  • K163652 — ePlex Instrument (June 9, 2017)
  • K163636 — ePlex Respiratory Pathogen Panel (June 9, 2017)
  • K152612 — eSensor Warfarin Sensitivity Saliva Test (May 26, 2016)

Other clearances for product code PEN

  • K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay (April 18, 2025)
  • K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RF (December 20, 2024)
  • K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel (March 18, 2020)
  • K190341 — iC-GN iC-Cassette for use on the iC-System (June 28, 2019)
  • K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 12, 2019)
  • K181493 — FilmArray Blood Culture Identification (BCID) Panel (July 5, 2018)
  • K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (March 15, 2016)
  • K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2 (January 30, 2015)
  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (June 21, 2013)

FDA data resources