# K262113: HardyDisk AST Tebipenem 10µg (TBP10)

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Aug 20, 2026 after 58 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 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 Tebipenem 10µg (TBP10) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales to tebipenem, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). HardyDisk AST Tebipenem at concentration 10μg demonstrated acceptable performance to determine the zone diameter (mm) of tebipenem against the following microorganisms: Enterobacterales (Escherichia coli, Enterobacter cloacae species complex, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter freundii complex, Citrobacter koseri, Klebsiella aerogenes, Morganella morganii, Proteus mirabilis, Providencia rettgeri, Klebsiella variicola, Serratia marcescens)

Source page: https://510kreport.com/device/K262113
Methodology: https://510kreport.com/methodology