# K261781: Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific (Oxoid Ltd.)
- Decided: Jul 24, 2026 after 56 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- 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
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro. The Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 is intended to determine susceptibility of Enterobacterales and Pseudomonas aeruginosa to cefepime/zidebactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 demonstrated acceptable performance to determine susceptibility to cefepime/zidebactam against the following microorganisms: Enterobacterales (Citrobacter braakii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens) Pseudomonas aeruginosa

Source page: https://510kreport.com/device/K261781
Methodology: https://510kreport.com/methodology