# K080998: Doripenem 10UG BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 12, 2008 after 35 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 µg): named in the summary without a submission number

## Recalls of this device
- Jan 8, 2024 · Class II · Z-1029-2024: 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 Doripenem 10 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 Doripenem. The concentration of 10 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: Streptococcus constellatus; Streptococcus intermedius Aerobic and facultative Gram-negative microorganisms: Acinetobacter baumannii; Escherichia coli; Klebsiella pneumoniae; Proteus mirabilis; Pseudomonas aeruginosa The safety and efficacy of doripenem in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Active In Vitro Against: Aerobic and facultative Gram-positive microorganisms: Staphylococcus aureus - (methicillin-susceptible isolates only); Streptococcus agalactiae; Streptococcus pyogenes Aerobic and facultative Gram-negative microorganisms: Citrobacter freundii; Enterobacter aerogenes; Enterobacter cloacae; Klebsiella oxytoca; Morganella morganii; Serratia marcescens

Source page: https://510kreport.com/device/K080998
Methodology: https://510kreport.com/methodology