(44 days)
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No
The device description details a traditional, manual method for antimicrobial susceptibility testing using impregnated paper discs and visual measurement of inhibition zones. There is no mention of automated analysis, algorithms, or any technology that would suggest the use of AI or ML.
No
The device is used for in vitro diagnostic testing to determine the susceptibility of bacteria to an antimicrobial agent, which helps in guiding treatment but is not a treatment itself.
Yes.
The device is used for in vitro susceptibility testing to determine the susceptibility of bacteria to Levofloxacin, which provides information for antimicrobial therapy. This is a diagnostic function because it identifies a characteristic of a pathogen that informs treatment decisions.
No
The device is described as physical discs impregnated with a chemical agent, which are used in a laboratory procedure involving agar plates and measurement of inhibition zones. This clearly involves hardware components and a physical process, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the discs are used for "semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures." The term "in vitro" is a key indicator of an IVD. It also specifies the purpose is to determine the "susceptibility of gram-positive and gram-negative bacteria" to Levofloxacin, which is a diagnostic purpose.
- Device Description: The description details how the discs are used in a laboratory setting with agar plates and bacterial cultures to perform a test that provides information about the bacteria's susceptibility. This process is characteristic of an in vitro diagnostic test.
- Comparison to Standards: The document mentions comparing zone sizes to established standards from the National Committee for Clinical Laboratory Standards (NCCLS) to determine if the organism is susceptible, intermediate, or resistant. This comparison is part of the diagnostic interpretation of the test results.
The entire context of the document describes a product used in a laboratory setting to perform a test on biological samples (bacterial cultures) to provide information relevant to diagnosing or treating a condition (bacterial infection). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Levofloxacin Sensi-Discs® are intended for use in determining the susceptibility of gram-positive and gram-negative bacteria, including Enteroccus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, and Pseudomonas aeruginosa species to Levofloxacin. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Ortho Pharmaceutical Corporation/McNeil Pharmaceutical, and received FDA approval under NDA No. 20-634.
Use of BBL® Levofloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Levofloxacin. Levofloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the Ortho Pharmaceutical Corporation/McNeil Pharmaceutical package insert for this antimicrobic.
Aerobic Gram-Positive Microorganisms
Enterococcus faecalis Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes
Aerobic Gram-Negative Microorganisms
- Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa
Product codes
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Device Description
Levofloxacin Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Levofloxacin supplied by the manufacturers, Ortho Pharmaceutical Corporation, Raritan, New Jersey, or McNeil Pharmaceutical, Raritan, New Jersey. Each Levofloxacin disc is clearly marked on both sides with the agent and content. Levofloxacin discs are furnished in cartridges of 50 discs each. Levofloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.
Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
Various requlatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95).
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae) inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
See attached Ortho Pharmaceutical Corporation/McNeil Pharmaceutical product insert section on Susceptibility Testing Diffusion Techniques for Levaquin™ (Levofloxacin).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Other BBL® Sensi-Discs® such as Ofloxacin. 5 mcg. Sensi-Disc®
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
MAR - 6 1997
Date 1/21/97
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems P.O. Box 243 Cockeysville, MD 21030-0243
NAME OF DEVICE:
| Trade Name: | Levofloxacin, 5 mcg, Sensi-Discs Catalog Numbers 4331705, 4331706 |
|---|---|
| Common Name/Description: | Antimicrobial Susceptibility Test Discs |
| Classification Name: | Antimicrobial Susceptibility Test Discs |
| PREDICATE DEVICE: | Other BBL® Sensi-Discs® such as Ofloxacin. 5 mcg. Sensi-Disc® |
DEVICE DESCRIPTION:
INTENDED USE:
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Levofloxacin Sensi-Discs® are intended for use in determining the susceptibility of gram-positive and gram-negative bacteria, including Enteroccus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, and Pseudomonas aeruginosa species to Levofloxacin. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Ortho Pharmaceutical Corporation/McNeil Pharmaceutical, and received FDA approval under NDA No. 20-634.
B-1
1
INDICATIONS FOR USE:
Use of BBL® Levofloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Levofloxacin. Levofloxacin has been shown to be active against most strains of microorganisms listed below, both in vitro and in clinical infections, as described in the Ortho Pharmaceutical Corporation/McNeil Pharmaceutical package insert for this antimicrobic.
Aerobic Gram-Positive Microorganisms
Enterococcus faecalis Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes
Aerobic Gram-Negative Microorganisms
- Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa
PRODUCT DESCRIPTION:
Levofloxacin Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Levofloxacin supplied by the manufacturers, Ortho Pharmaceutical Corporation, Raritan, New Jersey, or McNeil Pharmaceutical, Raritan, New Jersey. Each Levofloxacin disc is clearly marked on both sides with the agent and content. Levofloxacin discs are furnished in cartridges of 50 discs each. Levofloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.
Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
2
Various requlatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95).
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae) inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).
PERFORMANCE DATA:
See attached Ortho Pharmaceutical Corporation/McNeil Pharmaceutical product insert section on Susceptibility Testing Diffusion Techniques for Levaquin™ (Levofloxacin).
and the control of the country of the country
100 - 100 - 100
. . . . . . . .