# K250885: Ceftobiprole BPR 5 µg Disc

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem, Inc.
- Decided: Jun 23, 2025 after 90 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Liofilchem Antibiotic Discs are a semi-quantitative agar diffusion method for in vitro determination of antimicrobial susceptibility of clinical isolates tested on agar media after overnight incubation. The Ceftobiprole BPR 5 µg Disc is intended to determine susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Ceftobiprole at concentrations of 5 μg should be interpreted at 16-18 hours of incubation. The Ceftobiprole BPR 5 µg Disc demonstrated acceptable performance with the following organisms: Enterobacterales (Escherichia coli and Klebsiella pneumoniae) Staphylococcus aureus (includes methicillin resistant isolates)

Source page: https://510kreport.com/device/K250885
Methodology: https://510kreport.com/methodology