# K082272: Voriconazole 1UG BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 2, 2008 after 52 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
Longest line of descent: 1 generation back to K874425 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874425: Ciprofloxacin 5 MCG Sensi-Disc, Bd Becton Dickinson Vacutainer Systems Preanalytic (1987) Summary page 5.

## Indications for use
Use of Voriconazole 1 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 Voriconazole. The concentration of 1 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 Candida krusei Candida parapsilosis Candida tropicalis Active In Vitro Against: Candida lusitaniae Candida guilliermondii

Source page: https://510kreport.com/device/K082272
Methodology: https://510kreport.com/methodology