# K203741: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Dec 20, 2021 after 363 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 Cefiderocol in the dilution range of 0.03-64ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel. Cefiderocol has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Acinetobacter baurnannii Serratia marcescens

Source page: https://510kreport.com/device/K203741
Methodology: https://510kreport.com/methodology