MICROSTREP PLUS PANEL, LEVOFLOXACIN

• K Number: K983943
• Device Name: MICROSTREP PLUS PANEL, LEVOFLOXACIN
• Manufacturer: DADE MICROSCAN, INC.
• Date Cleared: 2000-02-18 ( 470 days)
• Product Code: JWY
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: K963641
• Predicate For: N/A

Intended Use

To determine bacterial susceptibility to Levofloxacin. For determining antimicrobic susceptibility of aerobic non-enterococcal streptococci including Streptococcus pneumoniae. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative andor qualitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercococcal streptococci, including or epice oose proam. This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.002 - 16 mcg/ml to the test panel. The organisms which may be used for Levofloxacin susceptibility testing in this panel are; I it organismis without may treptococci including Streptococcus pneumoniae.

Device Description

MicroScan® MICroSTREP plus™ Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® MICroSTREP plus™ Panel with Levofloxacin:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement with NCCLS frozen Reference Panel for Levofloxacin susceptibility	99% Essential Agreement
Reproducibility for Levofloxacin	Acceptable reproducibility
Quality Control testing for Levofloxacin	Acceptable results

Study Details

• Sample Size for Test Set and Data Provenance:

  • Sample Size: Not explicitly stated. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation.
  • Data Provenance: Not explicitly stated, though the use of "fresh" isolates suggests a prospective component, while "stock Efficacy isolates and stock Challenge strains" could be either retrospective or sourced from a library. The study compared the device to an "NCCLS frozen Reference Panel," which implies a standardized, possibly laboratory-derived, set of data.

• Number of Experts and Qualifications:

  • Not applicable. This device determines bacterial susceptibility, which is a quantitative measurement, not a subjective interpretation requiring human experts for ground truth establishment.

• Adjudication Method:

  • Not applicable. The test involves direct comparison to a reference standard with a quantitative outcome (MIC).

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No, an MRMC study was not done. The device is for automated or semi-automated susceptibility testing, not for aiding human readers in interpretation.

• Standalone (Algorithm-Only) Performance Study:

  • Yes, this was a standalone performance study. The "device" in this context (the MicroScan® MICroSTREP plus™ Panel) determines the MIC independently, and its results are then compared to a reference standard. The manual reading of the MIC is a step in using the device, but the performance evaluation is of the panel's ability to produce those results.

• Type of Ground Truth Used:

  • Reference Standard: The ground truth was established using an "NCCLS frozen Reference Panel." This is a standardized, well-defined reference method for antimicrobial susceptibility testing.

• Sample Size for Training Set:

  • Not applicable. This device is a diagnostic panel, not a machine learning algorithm that requires a separate training set. The development of the panel itself would involve optimization, but this isn't framed as a "training set" in the machine learning sense.

• How Ground Truth for Training Set Was Established:

  • Not applicable, as there isn't a training set in the context of a machine learning-based device. The reference standard (NCCLS frozen Reference Panel) serves as the benchmark against which the device's performance is measured.

Regulation Number and Section

§ 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).