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K Number
K231568
Device Name
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
Manufacturer
Hardy Diagnostics
Date Cleared
2023-07-06

(36 days)

Product Code
JTN
Regulation Number
866.1620
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffision test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candidas spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk™ AST Sulbactam 10/10ug (SUD20) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Sulbactam.

HardyDisk™ AST Sulbactam/Durlobactam at concentration 10/10ug can be used to determine the zone diameter (mm) of Sulbactam/Durlobactam against the following microorganisms for which Sulbactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC).

Device Description

HardyDisk™ AST Sulbactam/Durlobactam 10/10μg (SUD20)

AI/ML Overview

I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and an Indications for Use statement for the HardyDisk™ AST Sulbactam/Durlobactam 10/10µg (SUD20).

While it mentions the device's purpose (antimicrobial susceptibility testing) and the microorganisms it tests against, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample size for test sets or data provenance.
  • Information on experts used to establish ground truth or adjudication methods.
  • Any mention of a multi-reader, multi-case (MRMC) comparative effectiveness study.
  • Information about standalone algorithm performance.
  • The type of ground truth used (beyond implying susceptibility testing).
  • Sample size for the training set or how its ground truth was established.

This document confirms the device's clearance and intended use but does not delve into the underlying performance studies and acceptance criteria details that would typically be found in a more comprehensive submission summary or clinical study report.

§ 866.1620 Antimicrobial susceptibility test disc.

(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).