# K993186: Synercid, 15 UG, BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Nov 3, 1999 after 42 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 pg, BBL™ Sensi-Disc™: named in the summary without a submission number

## Indications for use
Use of Synercid, 15 ug, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Synercid. Synercid has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Rhone Paulenc-Rorer package insert for this antimicrobic. Active In Vitro Against: Asrobic Gram-Poslitive Microorganisms: Enterococcus faecium (Vancomycin-resistant and multi-grug resistant strains only) Staphylococcus aurays (methiclllin-susceptible strains only) Straptococcus pyogenes

Source page: https://510kreport.com/device/K993186
Methodology: https://510kreport.com/methodology