# K980683: Trovafloxacin 10G, Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: May 1, 1998 after 67 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K950653: Ciprofloxacin, 5 mcg, Sensi-Disc®. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
Use of BBL Trovafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Trovafloxacin. Trovafloxacin has been shown to be active against most strains of microorganisms listed below, as described in the Roerig package insert for this antimicrobic. Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Enterococcus faecalis (many only mod. suscept.) Staphylococcus aureus (meth. suscept.) Staphylococcus epidermidis (meth. suscept.) Streptococcus agalactiae Streptococcus pneumoniae (pen. suscept.) Streptococcus pyogenes Viridans group streptococci Aerobic Gram-Negative Microorganisms Escherichia coli Gardnerella vaginalis Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Neisseria gonorrhoeae Proteus mirabilis Pseudomonas aeruginosa Anaerobic Microorganisms Bacteroides fragilis Peptostreptococcus species Prevotella species Other Microorganisms Chlamydia pneumoniae Chlamydia trachomatis Legionella pneumophila Mycoplasma pneumoniae Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Streptococcus pneumoniae (penicillin-resistant strains) Aerobic Gram-Negative Microorganism Citrobacter freundii Enterobacter aerogenes Morganella morganii Proteus vulgaris Anaerobic Microorganisms Bacteroides distasonis Bacteroides ovatus Clostridium perfringens Other Microorganisms Mycoplasma hominis Ureaplasma urealyticum

Source page: https://510kreport.com/device/K980683
Methodology: https://510kreport.com/methodology