iC-GN Assay

Basic Information

• Brand Name: iC-GN Assay
• Primary DI: B769ICCAAQA00000
• Version / Model: iCC-AAQA00000
• Company Name: ICUBATE, INC
• Labeler DUNS: 830140377
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-15
• Public Version: 2
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: ebc00bb2-ee17-4320-856c-ea0579735099

Device Description

The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Microbiology	866.3365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63010	Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple bacterial species associated with bloodstream infection in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B769ICCAAQA00000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190341	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius