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510(k) K182619

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
September 24, 2018
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

  • K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 27, 2022)
  • 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)
  • K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 27, 2022)
  • 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)
  • 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)