# K190341: iC-GN iC-Cassette for use on the iC-System

- Pathway: 510(k) (Traditional)
- Applicant: Icubate, Inc.
- Decided: Jun 28, 2019 after 134 days
- Product code: PEN (Gram-Negative Bacteria And Associated Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN120014 (2012). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), Nanosphere, Inc. (2014) Summary page 4.

## Indications for use
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. Cultures demonstrating mixed Gram stain results should not be tested on the assay. The iC‐GN Assay™ is validated for use with select BACTEC™, BacT/ALERT® and VersaTREK® blood culture bottles. The iC‐GN Assay™ is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections. The iC‐GN Assay™ detects target DNA and identifies the following: Bacterial Genera and Species Resistance Markers Acinetobacter baumannii complex Enterobacter cloacae complex KPC (blaKPC)‐ associated with resistance to carbapenems Escherichia coli NDM (blaNDM)‐ associated with resistance to carbapenems Klebsiella oxytoca CTX‐M group 1(blaCTX‐M group 1)‐ associated with resistance to extended spectrum beta‐lactams Klebsiella pneumoniae Pseudomonas aeruginosa Proteus species Serratia marcescens In mixed growth, the iC‐GN Assay™ does not specifically attribute detection of KPC, NDM, or CTX‐M group 1 to a specific genera or species. Sub‐culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by the iC‐GN Assay™, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

Source page: https://510kreport.com/device/K190341
Methodology: https://510kreport.com/methodology