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K Number
K024353
Device Name
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2003-03-06

(66 days)

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

The Sensititre 18 - 24 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 Moxifloxacin in the dilution range of 0.004-16ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Moxifloxacin is for: Klebsiella pneumoniae. In vitro data, without clinical correlation is provided for: Citrobacter freundi, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, and Proteus mirablis.

Device Description

Susceptibility Test Panel

AI/ML Overview

This looks like a 510(k) clearance letter for an in vitro diagnostic device, specifically a Susceptibility Test Panel for antimicrobial susceptibility testing. The provided text does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a 510(k) summary or the full submission.

What is provided is:

  • Device Name: Susceptibility Test Panel (Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System)
  • Intended Use: In vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. Specifically, this 510(k) is for the addition of Moxifloxacin (0.004-16ug/ml) to the panel for gram-negative isolates, with approved primary indications for Klebsiella pneumoniae.
  • Regulatory Information: Class II device, Regulation Number 21 CFR 866.1640.
  • Date of Clearance: March 6, 2003

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and study results based only on the provided text. This document is a clearance letter, not the technical submission itself.

To answer your request, I would need access to the 510(k) summary or the full premarket notification for K024353, which would contain the study design, acceptance criteria, and performance data.

If you were to provide that information, I would be looking for the following sections within the submission:

  • Performance Data/Clinical Studies: This section would describe the studies conducted.
  • Acceptance Criteria: Often explicitly stated for various performance metrics (e.g., essential agreement, categorical agreement).
  • Test Methods: Details on how the device's results were compared to a reference method.
  • Ground Truth: How the true susceptibility/resistance was determined.
  • Sample Description: Details on the isolates used (number, type, source).

Without that technical information, I cannot generate the requested table or answer the specific questions about the study design.

§ 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).