# K171975: HardyDisk AST Delafloxacin 5 µg (DLX5)

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Aug 1, 2017 after 32 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
Use of HardyDisk™ AST Delafloxacin 5ug (DLX5), for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin. The concentration of Delafloxacin 5pug (DLXS5), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains) Staphylococcus haemolyticus Streptococcus pyogenes Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa The concentration of Delafloxacin Spg (DLXS5), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use: Streptococcus dysgalactiae Enterobacter aerogenes Haemophilus parainfluenzae Klebsiella oxytoca Proteus mirabilis 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.

Source page: https://510kreport.com/device/K171975
Methodology: https://510kreport.com/methodology