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K Number
K982669
Device Name
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
1998-09-09

(40 days)

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

Antimicrose Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. Streptomycin 300 Susceptibility Test Discs are for the screening of Enterococcus of 'high level antibiotic resistance'.

Device Description

Oxoid Streptomycin Susceptibility Test Disc

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding a 510(k) submission for an antimicrobial susceptibility test disc. It discusses regulatory matters, but it does not detail:

  1. Acceptance criteria or device performance.
  2. Sample sizes or data provenance for a test set.
  3. Details about expert qualifications or numbers for ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case study information.
  6. Standalone performance studies.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the input text.

§ 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).