# K113371: Staphylococcus Quickfish BC

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Apr 3, 2012 after 139 days
- Product code: NXX (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus)
- Device class: 1
- Regulation: 21 CFR 866.3700
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jul 4, 2014 · Class II · Z-2138-2014: Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

## Indications for use
The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulase-negative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth. Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.

Source page: https://510kreport.com/device/K113371
Methodology: https://510kreport.com/methodology