HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231568 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 Sulbactam/Durlobactam 10/10µg (SUD20) is an antimicrobial susceptibility test disc. It consists of an impregnated paper disc used for semi-quantitative in vitro susceptibility testing of rapidly growing and certain fastidious bacteria via the agar diffusion test procedure, also known as Kirby-Bauer testing.
This device is intended for use in determining the susceptibility of microorganisms to Sulbactam/Durlobactam. It has received FDA 510(k) clearance under the product code JTN and regulation number 866.1620.
Frequently asked questions
What is the intended use of the HardyDisk AST Sulbactam/Durlobactam disc?
This device is designed for semi-quantitative in vitro antimicrobial susceptibility testing. It is used to determine the susceptibility of rapidly growing and certain fastidious bacteria to the combination of Sulbactam and Durlobactam using the agar diffusion or Kirby-Bauer test procedure.
What is the regulatory status of this antimicrobial susceptibility test disc?
The HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) has received FDA 510(k) clearance under K-number K231568. It is classified under regulation number 866.1620 and product code JTN, indicating it has been found substantially equivalent to legally marketed predicate devices.
How is the HardyDisk AST disc utilized in a laboratory setting?
The product consists of an impregnated paper disc that is placed onto an agar plate inoculated with the target microorganism. As the antibiotic diffuses into the agar, the zone of inhibition is measured to assess the susceptibility of the bacteria, following standard Kirby-Bauer testing protocols.
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 Sulbactam-Durlobactam, SUD20 - Hardy Diagnostics, PDF Instructions for Use - Hardy Diagnostics, HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (K231568) — FDA 510 ..., K231568 - HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231568 | Class II | Active |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA 510(k) K231568 24 fields · synced Sep 25, 2026