510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163390Substantially Equivalent

iC-GPC Assay TM for use on the iC-SystemTM

Icubate, Inc., Huntsville AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163390 is the FDA 510(k) clearance record for iC-GPC Assay TM for use on the iC-SystemTM, a class II device, cleared for Icubate, Inc. on under FDA product code PAM (Gram-Positive Bacteria And Their Resistance Markers). FDA's definition for product code PAM reads: "A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures". FDA records list 2 510(k) clearances for Icubate, Inc., from to . As of , FDA records show no recalls naming K163390.

Clearance record

Decision date
Received
(249 days to decision)
Product code
PAM Gram-Positive Bacteria And Their Resistance Markers
Regulation
21 CFR 866.3365
Device class
Class II
Review panel
Microbiology
Applicant
Icubate, Inc. 601 Genome Way, Huntsville AL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAM

Trailing 12 months
1 clearance under product code PAM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260