# K253105: HardyDisk AST Cefiderocol 30µg (FDC30)

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Nov 20, 2025 after 57 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jun 8, 2026 · Class II · Z-2887-2026: Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimic

## 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 Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae. Use of HardyDisk AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to cefiderocol, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). HardyDisk AST Cefiderocol at concentration 30μg demonstrated acceptable performance to determine the zone diameter (mm) of cefiderocol against the following microorganisms: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, and Serratia marcescens) Pseudomonas aeruginosa Acinetobacter baumannii complex Stenotrophomonas maltophilia

Source page: https://510kreport.com/device/K253105
Methodology: https://510kreport.com/methodology