HardyDisk AST Cefiderocol 30µg (FDC30)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253105 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)
The HardyDisk AST Cefiderocol 30µg (FDC30) is an antimicrobial susceptibility test disc, classified as a susceptibility test disc under the nomenclature authority. It is a 6mm filter paper disc impregnated with 30 micrograms of cefiderocol, designed for semi-quantitative in vitro antimicrobial susceptibility testing (AST).
This device is supplied in cartridges of 50 discs, compatible with BBL single or multiple disk dispensers. It is intended for single-use in microbiology laboratories and is not sterile. The device is regulated under FDA 510(k) clearance (K253105) and falls under Class II medical devices, adhering to FDA regulation 866.1620. Storage and handling should follow standard microbiological practices.
Frequently asked questions
What is the HardyDisk AST Cefiderocol 30µg (FDC30) used for in a lab setting?
The HardyDisk AST Cefiderocol 30µg (FDC30) is designed for semi-quantitative in vitro antimicrobial susceptibility testing (AST). This means it helps determine whether bacteria are susceptible, intermediate, or resistant to cefiderocol, aiding in guiding appropriate antibiotic treatment decisions in microbiology labs.
How is the HardyDisk AST Cefiderocol 30µg (FDC30) supplied, and what dispensers can be used with it?
The device comes in cartridges containing 50 discs each. It is compatible with BBL single or multiple disk dispensers, which streamline the process of applying discs to culture plates during AST procedures.
Is the HardyDisk AST Cefiderocol 30µg (FDC30) intended for single-use or repeated use?
The HardyDisk AST Cefiderocol 30µg (FDC30) is explicitly designed for single-use only in microbiology laboratories. This ensures accuracy and prevents cross-contamination, which is critical for reliable antimicrobial susceptibility testing.
What storage and handling precautions should be taken with the HardyDisk AST Cefiderocol 30µg (FDC30)?
While the device itself is not sterile, it must be stored and handled according to standard microbiological practices. This includes protecting it from contamination, moisture, and extreme temperatures to maintain its integrity and performance for accurate AST results.
What regulatory pathway was followed for the FDA clearance of the HardyDisk AST Cefiderocol 30µg (FDC30)?
The device was cleared through the FDA’s 510(k) pathway, specifically under a *Traditional* review process with a *Substantially Equivalent* determination. It falls under Class II medical devices and adheres to FDA regulation 866.1620, with clearance number K253105.
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: HardyDisk™ AST Cefiderocol, FDC30 - Hardy Diagnostics, Hardy Diagnostics™ HardyDisks™ Cefiderocol, FDC30, Fetroja, HardyDisks™ for Antibiotic Resistance/Antibiotic ... - Hardy Diagnostics, HardyDisk AST Cefiderocol 30µg (FDC30) (K253105) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253105 | Class II | Active |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA 510(k) K253105 24 fields · synced Sep 19, 2026