# K112586: Ceftaroline 30 Micrograms, BBL (TM) Sensi-Disc (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company (BD)
- Decided: Oct 18, 2011 after 42 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: 1 (0 Class I)
- 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 BBL Sensi-Disc (e.g., Ciprofloxacin 5 mcg, BBL Sensi-Disc): named in the summary without a submission number

## Recalls of this device
- Jan 8, 2024 · Class II · Z-1022-2024: There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adv

## Indications for use
Use of Ceftaroline 30pg, BBL Sensi-Disc for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30pg 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: Gram-positive Microorganisms Gram-negative Microorganisms Staphylococcus aureus (including methicillin-susceptible and Escherichia coi -resistant isolates) Kiebsiella pneumoniae Streptococcus pyo genes Kiebsiella oxytoca Streptococcus agalactiae Haemophllus influenzae Streptococcus pneuimoniae Active In Vitro Against: Gram-positive Microorganisms Gram-negative Microorganisms Streptococcus dysgalactiae Citrobacter koseri Citrobacter freundil Enterobacter cloace Entemobacter aero genes Moraxella catarrhalis Morganella morganli Proteus mira bills Haemophilus parainfluenzae

Source page: https://510kreport.com/device/K112586
Methodology: https://510kreport.com/methodology