# K123418: Gram-Negative Quickfish BC

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Jul 21, 2013 after 257 days
- Product code: JSS (Kit, Identification, Enterobacteriaceae)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K150031: hemoFISH Masterpanel (2015), 0 descendants of its own

## Recalls of this device
- Dec 11, 2013 · Class III · Z-0619-2014: Kits incompatible with certain fluorescence microscope light sources

Source page: https://510kreport.com/device/K123418
Methodology: https://510kreport.com/methodology