# K182357: HardyDisk AST Eravacycline 20µg (ERV20)

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Sep 26, 2018 after 27 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
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk AST Eravacycline 20μg (ERV20) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria among the Enterobacteriaceae to Eravacycline. HardyDisk AST Eravacycline at concentration 20μg can be used to determine the zone diameter (mm) of Eravacycline against the following bacteria among the Enterobacteriaceae. Eravacycline has been shown to be active both clinically and in vitro against the following organisms: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes.

Source page: https://510kreport.com/device/K182357
Methodology: https://510kreport.com/methodology