# K232276: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid Limited (Part of Thermo Fisher Scientific)
- Decided: Oct 6, 2023 after 67 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 Sulbactam/Durlobactam Disc (10/10 µg) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam/Durlobactam has been shown to be active both clinically and in vitro: Acinetobacter-baumannii calcoaceticus complex

Source page: https://510kreport.com/device/K232276
Methodology: https://510kreport.com/methodology