# K052853: Tigecycline 15UG BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 17, 2005 after 37 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 Tigecycline 15 µg BBL Sensi-Disc for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Tigecycline. The concentration of 15 µg 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 facultative Gram-positive microorganisms Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus (methicillin susceptible and resistant isolates only) Streptococcus agalactiae Streptococcus anginosus grp. (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes Aerobic and facultative Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Active In Vitro Against: Aerobic and facultative Gram-positive microorganisms Enterococcus avium Enterococcus casseliflavus Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Enterococcus gallinarum Listeria monocytogenes Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates) Staphylococcus haemolyticus Aerobic and facultative Gram-negative microorganisms Acinetobacter baumannii Aeromonas hydrophila Citrobacter koseri Enterobacter aerogenes Pasteurella multocida Serratia marcescens Stenotrophomonas maltophilia

Source page: https://510kreport.com/device/K052853
Methodology: https://510kreport.com/methodology