# K210873: Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid Limited (Part of Thermo Fisher Scientific)
- Decided: Oct 27, 2021 after 217 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. The Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20 can be used to determine susceptibility to Lefamulin against the following bacteria for which Lefamulin has been shown to be active both clinically and in vitro: Gram-positive Bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates) Gram-negative Bacteria Haemophilus influenzae

Source page: https://510kreport.com/device/K210873
Methodology: https://510kreport.com/methodology