# K082271: Fluconazole 25UG BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 6, 2008 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. The FDA summary names its predicate without a number.
- (no number) BBL Sensi-Disc Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg: named in the summary without a submission number

## Indications for use
Use of Fluconazole 25 µg BBL Sensi-Disc for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Fluconazole. The concentration of 25 µg has been shown to be active in vitro against most strains of Candida species listed below, as described in the FDA approved drug insert for this agent. Active In Vitro and in Clinical Infections Against: Candida albicans Candida glabrata (Many strains are intermediately susceptible) Candida parapsilosis Candida tropicalis Active In Vitro Against: Candida dubliniensis Candida guilliermondii Candida kefyr Candida lusitaniae

Source page: https://510kreport.com/device/K082271
Methodology: https://510kreport.com/methodology