# K994067: Hardy Disk Ampicillin/Sulbactam

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Jan 14, 2000 after 44 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™ Antimicrobial Sensitivity 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., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. HardyDisk™ Ampicillin/Sulbactam is indicated for in vitro activity against gram negative organisms including Escherichia coli, Klebsiella spp., Proteus spp., Providencia spp., Morganella morganii, Haemophilus spp. and Neisseria gonorrhoeae. HardyDisk™ Ampicillin/Sulbactam is also indicated for in vitro activity against gram positive organisms including Staphylococcus spp., enterococci, and Streptococcus spp., including S. pneumoniae.

Source page: https://510kreport.com/device/K994067
Methodology: https://510kreport.com/methodology