# K121991: Enterococcus Quickfish BC

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Jan 7, 2013 after 185 days
- Product code: OAH (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing gram- positive cocci in pairs and chains observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.

Source page: https://510kreport.com/device/K121991
Methodology: https://510kreport.com/methodology