# K100722: Telavancin 30 UG, BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 29, 2010 after 14 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 Telavancin 30µg, BBL Sensi-Disc for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Telavancin. The concentration of 30µg 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: Facultative Gram-positive Microorganisms Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus) Active In Vitro Against: Facultative Gram-positive Microorganisms Enterococcus faecium (vancomycin-susceptible isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp. equisimilis Staphylococcus epidermidis

Source page: https://510kreport.com/device/K100722
Methodology: https://510kreport.com/methodology