K Number
K984608
Manufacturer
Date Cleared
1999-03-09

(71 days)

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

Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Gentamicin 120µg these include Enterococcus spp. Gentamicin 120 Susceptibility Test Discs are for detection of 'high level antibiotic resistance'.

Device Description

Oxoid Gentamicin Susceptibility Test Disc

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Oxoid Gentamicin Antimicrobial Susceptibility Test Disc. It does not contain the detailed study information required to answer the prompt. The letter merely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information, such as acceptance criteria, device performance, sample sizes, ground truth establishment, or details about any comparative effectiveness studies, based on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

§ 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).