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510(k) K181663

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel by Genmark Diagnostics, Incorporated — Product Code PAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2018
Date Received
June 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

Other clearances by Genmark Diagnostics, Incorporated

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

  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K163390 — iC-GPC Assay TM for use on the iC-SystemTM (August 8, 2017)
  • K152470 — Great Basin Staph ID/R Blood Culture Panel (March 25, 2016)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)