# K974578: Grepafloxacin, 5 MG, Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Feb 23, 1998 after 77 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) Ciprofloxacin, 5 mcg, Sensi-Disc: named in the summary without a submission number

## Indications for use
Use of BBL Grepafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Grepafloxacin. Grepafloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the GlaxoWellcome package insert for this antimicrobic. Aerobic Gram-Positive Microorganisms Streptococcus pneumoniae (penicillin-susceptible strains) Aerobic Gram-Negative Microorganisms Haemophilus influenzae Neisseria gonorrhoeae Moraxella catarrhalis Other microorganisms: Chlamydia trachomatis Mycoplasma pneumoniae Grepafloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 1ug/ml or less against most (>90%) strains of the following microorganisms; however, the safety and effectiveness of grepafloxacin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Aerobic Gram-Positive Microorganisms (In Vitro Only) Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-resistant strains) Streptococcus pyogenes Aerobic Gram-Negative Microorganisms (In Vitro Only) Citrobacter freundii Citrobacter (diversus) koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris

Source page: https://510kreport.com/device/K974578
Methodology: https://510kreport.com/methodology