# K163390: iC-GPC Assay TM for use on the iC-SystemTM

- Pathway: 510(k) (Traditional)
- Applicant: Icubate, Inc.
- Decided: Aug 8, 2017 after 249 days
- Product code: PAM (Gram-Positive Bacteria And Their 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: 2 generations back to DEN120014 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test, Nanosphere, Inc. (2012) Summary page 6.

## Indications for use
The iCubate iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci. Cultures demonstrating mixed Gram stain results should not be tested with the assay. The iC-GPC Assay is validated for use with select BACTEC, BacT/ALERT and VersaTREK blood culture bottles. The iC-GPC Assay is indicated for use in conjunction with other clinical and laboratory findings, such as blood culture isolate identification and antimicrobial susceptibility testing, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections. The iC-GPC Assay detects organism DNA and identifies the following bacterial species and resistance markers: Bacterial Species Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Enterococcus faecalis Enterococcus faecium Resistance Markers mecA- associated with methicillin resistance vanA- associated with vancomycin resistance vanB- associated with vancomycin resistance The iC-GPC Assay detects the mecA resistance marker, inferring mecA-mediated methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, the iC-GPC Assay does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by the iC-GPC 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/K163390
Methodology: https://510kreport.com/methodology