# K050062: Gemifloxacin, 5UG BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 10, 2005 after 30 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) Other BBL Sensi-Disc (e.g., Ciprofloxacin 5 µg, BBL Sensi-Disc): named in the summary without a submission number

## Indications for use
Use of Gemifloxacin 5[ig, BBL Sensi-Disc for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Gemifloxacin. 5.g has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic. Active In Vitro and in clinical infections against: Aerobic gram-positive microorganisms Streptococcus pneumoniae (including multidrug resistant strains) Aerobic gram-negative microorganisms Haemophilus influenzae Haemophilusparainfiuenzae Klebsiella pneumoniae (many strains are only moderately susceptible) Active In Vitro Against: Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pyogenes Aerobic gram-negative microorganisms Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris

Source page: https://510kreport.com/device/K050062
Methodology: https://510kreport.com/methodology