# K993577: Cefotaxime/Clavulanic, 30/10UG, BBL Sensi-Disc and Ceftazidime/Clavulanic Acid, 30/10UG, BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Dec 1, 1999 after 41 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) Cefotaxime, 30ug, BBL™ Sensi-Disc™: named in the summary without a submission number
- (no number) Ceftazidime, 30ug, BBL™ Sensi-Disc™: named in the summary without a submission number

## Indications for use
Antimicrobial susceptibility test discs are used for semi-quantitative susceptibility testing by standardized agar diffusion. Cefotaxime/Clavulanic Acid, BBL™ Sensi-Disc™ and Ceftazidime/Clavulanic Acid BBL™ Sensi-Disc™ are intended for use for confirmatory tests for organisms that secrete Extended-spectrum B-lactamases (ESBLs) as indicated in the Results section of the package insert and indicated below. Use of Cefotaxime/Clavulanic Acid, BBL™ Sensi-Disc™ and Ceftazidime/Clavulanic Acid, BBL™ Sensi-Disc™ together with Cefotaxime and Ceftazidime susceptibility discs for in vitro agar diffusion susceptibility testing are indicated when there is a need to perform a confirmatory test for ESBLs in Klebsiella spp. and Escherichia coli.

Source page: https://510kreport.com/device/K993577
Methodology: https://510kreport.com/methodology