# K092166: S. Aureus/CNS Pna Fish, Model KT005

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Nov 23, 2009 after 125 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: 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
S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain. Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth. S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

Source page: https://510kreport.com/device/K092166
Methodology: https://510kreport.com/methodology