Home / 510(k) Clearances / K190341

510(k) K190341

iC-GN iC-Cassette for use on the iC-System by Icubate, Inc. — Product Code PEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2019
Date Received
February 14, 2019
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 Icubate, Inc.

  • K163390 — iC-GPC Assay TM for use on the iC-SystemTM (August 8, 2017)

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)
  • 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)