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510(k) K163390

iC-GPC Assay TM for use on the iC-SystemTM by Icubate, Inc. — Product Code PAM

K163390 is an FDA 510(k) premarket notification submitted by Icubate, Inc. for the device "iC-GPC Assay TM for use on the iC-SystemTM". The FDA issued a decision of Substantially Equivalent on August 8, 2017. The device falls under product code PAM (Gram-Positive Bacteria And Their Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Icubate, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
December 2, 2016
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 Icubate, Inc.

  • K190341 — iC-GN iC-Cassette for use on the iC-System (June 28, 2019)

Other clearances for product code PAM

  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (December 20, 2018)
  • 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)

FDA data resources