# K193508: Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid Limited (Part of Thermo Fisher Scientific)
- Decided: Dec 4, 2020 after 352 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 (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Thermo Scientific Oxoid Eravacycline Disc (20pg) ERV20 can be used to determine susceptibility to Eravacycline against the following bacteria for which Eravacycline has been shown to be active both clinically and in vitro: Gram-negative bacteria: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae In vitro data are available for the following microorganisms, but clinical significance is unknown: Gram-negative bacteria: Citrobacter koseri Klebsiella aerogenes

Source page: https://510kreport.com/device/K193508
Methodology: https://510kreport.com/methodology