# K203336: Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid Limited (Part of Thermo Fisher Scientific)
- Decided: Sep 15, 2022 after 672 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 Omadacycline Disc (30μg) OMC 30 can be used to determine susceptibility to Omadacycline against the following bacteria for which Omadacycline has been shown to be active both clinically and in vitro: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Enterobacter cloacae Klebsiella pneumoniae Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis Streptococcus anginosus group (Streptococcus anginosus only) Streptococcus pyogenes For Community Acquired Bacterial Pneumonia (CABP): Klebsiella pneumoniae Staphylococcus aureus (methicillin-susceptible isolates only) Haemophilus species (Haemophilus influenzae, Haemophilus parainfluenzae) Streptococcus pneumoniae

Source page: https://510kreport.com/device/K203336
Methodology: https://510kreport.com/methodology