# K133773: Sensititre 18-24 Hour Mic Suceptibility System

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Feb 27, 2014 after 77 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 Sensititreo 18 -24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 51 0(k) is for mhe removal of the limitation for the ability to detect resistance for Meropenem (0.004 - 8pg/mL) and Enterobacterlaceae and for the addition of the newly approved breakpoints (S:91,I1=2, R?4) on the Sensititreo 18 -24 hour MIC panel for testing Gram negative Isolates. The approved primary, aindications for Uses and clinical significance for Enterobacterlaceas is for the following species: Esoher/chia cal Kiebs/ella pneumoniae Proteus mirabilis In vitro data, without clinical correlation Is provided for: Aeromonas hydra ph/Ia Citrobacter koseri (formerly divers us) Citrobacter freundli Enterobacter ctoacae Ha tn/a alvel Kiebsiella oxytaca Morganella morgan/il Proteus vulgaris Serratia marcescens

Source page: https://510kreport.com/device/K133773
Methodology: https://510kreport.com/methodology