# K101558: GNR Traffic Light Pna Fish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Dec 16, 2010 after 195 days
- Product code: JSS (Kit, Identification, Enterobacteriaceae)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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
GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia colt, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram- negative rods observed on Gram stain. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of E. colt, and/or K, pneumoniae, and/or P. aeruginosa bacteremia.

Source page: https://510kreport.com/device/K101558
Methodology: https://510kreport.com/methodology