LogoFDA 510(k) Search
K Number
K081063
Device Name
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2009-03-06

(326 days)

Product Code
NGZ
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for voriconazole in the dilution range of 0.008 - 16μg/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of voriconazole is for: Candida albicans Candida krusei Candida parapsilosis Candida tropicalis

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for the Sensititre® YeastOne® Susceptibility plates with Voriconazole, not a study evaluating an AI/ML powered device. The document describes the device, its indication for use, and confirms its substantial equivalence to a legally marketed predicate device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, ground truth establishment, or AI/ML performance metrics.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
  6. If a standalone (algorithm only) performance was done.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).