Identifiers
- 510(k) Number
- K250885 FDA 510(k)
- FDA Product Code
- JTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1620 FDA 510(k)
- Regulation Number
- 866.1620 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a susceptibility test disc, antimicrobial, used for in vitro determination of antimicrobial susceptibility. It is intended to determine susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
The device is supplied as a disc for use in agar diffusion methods after overnight incubation on agar media. It is a single-use device intended for microbiology laboratory settings and has received FDA 510(k) clearance under K250885 with product code JTN and regulation number 866.1620.
Frequently asked questions
What is the Ceftobiprole BPR 5 µg Disc used for?
The Ceftobiprole BPR 5 µg Disc is used for in vitro determination of antimicrobial susceptibility, specifically to assess the susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole using agar diffusion methods after overnight incubation, as defined by FDA Susceptibility Test Interpretive Criteria.
How is the Ceftobiprole BPR 5 µg Disc supplied and is it reusable?
The device is supplied as a paper disc containing 5 µg of ceftobiprole for use in agar diffusion testing. It is intended for single-use only in microbiology laboratory settings and must be discarded after each test to prevent cross-contamination and ensure accurate results.
What regulatory clearance does the Ceftobiprole BPR 5 µg Disc have?
The Ceftobiprole BPR 5 µg Disc has received FDA 510(k) clearance under submission number K250885, classified under product code JTN and regulation number 866.1620, and is deemed substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 9242/2 - Ceftobiprole BPR 5 µg - liofilchem.com, PDF 9242_IFU-1_ATB-BPR_US-definitive - liofilchem.com, Ceftobiprole BPR 5 µg Disc (K250885) — FDA 510(k) | Innolitics, PDF 9242_IFU-1_ATB-BPR_US-definitive - liofilchem.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250885 | Class II | Active |
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Manufacturer
- Manufacturer
- Liofilchem, Inc.
Sources (1)
- FDA 510(k) K250885 24 fields · synced Oct 1, 2026