# K150556: Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Aug 28, 2015 after 177 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 Ceftolozane/Tazobactam in the dilution range of 0.03/4 - 64/4 μg/mL for testing non-fastidious gram negative organisms on the Sensititre 18-24 hour MIC panel. The approved primary “Indications for Use” and clinical significance for non-fastidious Gram negative isolates: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Source page: https://510kreport.com/device/K150556
Methodology: https://510kreport.com/methodology