# K152838: HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Nov 24, 2015 after 56 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 Ceftazidime/Avibactam, (30/20ug) - CZAS50, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftazidime/Avibactam. The concentration of Ceftazidime/Avibactam, (30/20pg) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with in vitro use: Morganella morganii, Providencia rettgeri, and Serratia marcescens. The concentration of Ceftazidime/Avibactam, (30/20pg) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with both in vitro and in clinical infections: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Citrobacter freundii, Citrobacter koseri, Proteus spp., and Enterobacter acrogenes.

Source page: https://510kreport.com/device/K152838
Methodology: https://510kreport.com/methodology