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K Number
K983301
Device Name
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
Manufacturer
ACCUMED INTL., INC.
Date Cleared
1998-11-25

(65 days)

Product Code
JWY
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 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, and ground truth establishment for a medical device.

The document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin." This letter indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. While it mentions the "indications for use" and the product code, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or the type of study conducted to demonstrate performance (e.g., test set, training set, retrospective/prospective).
  • Information about experts used for ground truth, adjudication methods, or the type of ground truth.
  • Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The letter is a regulatory document confirming clearance, not a scientific study report with performance metrics.

To answer your questions, I would need access to the actual 510(k) submission document or a scientific paper detailing the validation study for this device.

§ 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).