HardyDisk AST Delafloxacin 5 µg (DLX5)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171975 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 Delafloxacin 5 µg (DLX5) consists of 6-mm diameter filter paper disks impregnated with 5 µg of the antimicrobial agent delafloxacin. These susceptibility test discs are used in clinical microbiology laboratories for semi-quantitative in vitro antimicrobial susceptibility testing via the Kirby-Bauer agar diffusion method.
The device is supplied in cartridges containing 50 disks, which are compatible with single or multiple disk dispensers. This product has received FDA 510(k) clearance under the classification of antimicrobial susceptibility test discs.
Frequently asked questions
What is the intended use of the HardyDisk AST Delafloxacin 5 µg?
These discs are designed for use in clinical microbiology laboratories to perform semi-quantitative in vitro antimicrobial susceptibility testing. They utilize the Kirby-Bauer agar diffusion method to determine the susceptibility of microorganisms to the antimicrobial agent delafloxacin.
How is the HardyDisk AST Delafloxacin supplied?
The product is supplied in cartridges containing 50 filter paper discs each. These cartridges are specifically designed to be compatible with both single and multiple disc dispensers to facilitate efficient laboratory workflow.
What is the regulatory status of this device?
The HardyDisk AST Delafloxacin 5 µg (DLX5) has received FDA 510(k) clearance under the classification of antimicrobial susceptibility test discs. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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 Delafloxacin, DLX5, HardyDisks™ for Antibiotic Resistance/Antibiotic ... - Hardy Diagnostics, HardyDisk AST Delafloxacin 5 µg (DLX5) - Innolitics, K171975 FDA 510(k) - HardyDisk AST Delafloxacin 5 µg (DLX5)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171975 | Class II | Active |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA 510(k) K171975 24 fields · synced Sep 26, 2026