# K150031: hemoFISH Masterpanel

- Pathway: 510(k) (Traditional)
- Applicant: Miacom Diagnostics GmbH
- Decided: Oct 1, 2015 after 266 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
Longest line of descent: 1 generation back to K123418 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123418: Gram-Negative Quickfish BC, Advandx, Inc. (2013) Summary page 5.

## Indications for use
hemoFISH Masterpanel is a qualitative nucleic acid hybridization assay performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain and is intended for the identification of the following species / genera / families: Gram-positive Gram-negative Staphylococcus spp. Enterobacteriaceae Staphylococcus aureus Escherichia coli Streptococcus spp. Klebsiella pneumoniae The hemoFISH Masterpanel is indicated as an aid in the diagnosis of specific agents of bacteremia and results should be used in conjunction with other clinical and laboratory findings. Positive hemoFISH Masterpanel results do not rule out co-infection with organisms not included in the hemoFISH Masterpanel. The hemoFISH Masterpanel is not intended to monitor treatment for bacteremia. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not identified by the hemoFISH Masterpanel, and for species determination of Staphylococcus spp., Streptococcus spp., and Enterobacteriaceae that are not identified by the hemoFISH Masterpanel.

Source page: https://510kreport.com/device/K150031
Methodology: https://510kreport.com/methodology