LEVOFLOXACIN, 5MCG, SENSI-DISC

K970212 · Becton Dickinson Microbiology Systems · JTN · Mar 6, 1997 · Microbiology

Device Facts

• Record ID: K970212
• Device Name: LEVOFLOXACIN, 5MCG, SENSI-DISC
• Applicant: Becton Dickinson Microbiology Systems
• Product Code: JTN · Microbiology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

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 Enterococcus 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.

Device Story

Levofloxacin Sensi-Discs consist of high-quality paper impregnated with 5 mcg of Levofloxacin. Used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing via standardized agar diffusion (Bauer-Kirby method). Discs are applied to inoculated Mueller Hinton Agar plates (or specialized media for specific organisms). Following incubation, healthcare professionals measure zones of inhibition surrounding the discs. Measured zone sizes are compared against established NCCLS (M2-A5, M100-S6) interpretive criteria to classify organisms as susceptible, intermediate, or resistant. This process assists clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

No clinical data provided. Performance is based on established standardized agar diffusion techniques and interpretive criteria defined by the drug manufacturer (Ortho Pharmaceutical/McNeil Pharmaceutical) and NCCLS standards.

Technological Characteristics

High-quality paper discs impregnated with 5 mcg Levofloxacin. Form factor: 50-disc cartridges. Principle: Agar diffusion (Bauer-Kirby method). Standards: NCCLS M2-A5 and M100-S6. No electronic, software, or energy-based components.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to Levofloxacin. Target organisms include aerobic Gram-positive (E. faecalis, S. aureus, S. pneumoniae, S. pyogenes) and Gram-negative (E. cloacae, E. coli, H. influenzae, H. parainfluenzae, K. pneumoniae, M. catarrhalis, P. mirabilis, P. aeruginosa) bacteria.

Regulatory Classification

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.

Predicate Devices

• Ofloxacin, 5 mcg, Sensi-Disc®

Submission Summary (Full Text)

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K970212

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 *Enterococcus 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.

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# 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.

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Various regulatory 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).