# K152516: BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Oct 13, 2015 after 40 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) Other BD BBL™ Sensi-Disc™ (e.g., Ciprofloxacin 5 µg, BD BBL™ Sensi-Disc™): named in the summary without a submission number

## Indications for use
Use of BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20µg) for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftazidime avibactam. The concentration of 30/20µg 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: Complicated Intra-abdominal Infections (cIAI) Gram-negative Microorganisms Escherichia coli Enterobacter cloacae Klebsiella pneumoniae Klebsiella oxytoca Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa Complicated Urinary Tract Infections (cUTI), including Pyelonephritis Gram-negative Microorganisms Citrobacter freundii Citrobacter koseri Escherichia coli Pseudomonas aeruginosa Enterobacter aerogenes Enterobacter cloacae Proteus spp. Klebsiella pneumoniae Active In Vitro Against: Gram-negative Microorganisms Morganella morganii Providencia rettgeri Serratia marcescens

Source page: https://510kreport.com/device/K152516
Methodology: https://510kreport.com/methodology