# K181946: Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Aug 8, 2018 after 19 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for Plazomicin in the dilution range of 0.06-128 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel. Plazomicin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: o Escherichia coli o Klebsiella pneumoniae o Proteus mirabilis o Enterobacter cloacae The following in vitro data are available, but their clinical significance is unknown. Gram-negative Bacteria o Citrobacter freundii o Citrobacter koseri o Klebsiella aerogenes o Klebsiella oxytoca o Morganella morganii o Providencia stuartii o Serratia marcescens o Proteus vulgaris

Source page: https://510kreport.com/device/K181946
Methodology: https://510kreport.com/methodology