# K103538: Hardydisk Ast Ceftaroline, 30 UG Model Z939

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Dec 17, 2010 after 15 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 HardyDiskTM Ceftaroline 30 pg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of Cefiaroline 30 pg has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pneunzoniae, Streptococcus pyogenes, Streptococcus agalactiae,Eseherichia coli, Kiebsiella pneumoniae, Kiebsiella oxytoc, and Haemophilus influenza.

Source page: https://510kreport.com/device/K103538
Methodology: https://510kreport.com/methodology