CEFEPIME, 30 MCG, SENSI-DISC

K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · JTN · Apr 5, 1996 · Microbiology

Device Facts

• Record ID: K961188
• Device Name: CEFEPIME, 30 MCG, SENSI-DISC
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: JTN · Microbiology
• Decision Date: Apr 5, 1996
• 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. Cefepime Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Enterobacter spp, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, and Streptococcus pyogenes (Lancefield’s Group A streptococci), to Cefepime. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Bristol-Myers Squibb, and received FDA approval under NDA No. 50-679.

Device Story

Cefepime Sensi-Discs consist of high-quality paper impregnated with specific concentrations of the antimicrobial agent Cefepime. Used in clinical microbiology laboratories by technicians; discs are applied to the surface of inoculated agar plates (e.g., Mueller Hinton Agar). Following incubation, the resulting zones of inhibition are measured. These measurements are compared against established zone size ranges (per NCCLS standards) to classify the organism as susceptible, intermediate, or resistant to Cefepime. This information assists healthcare providers in selecting appropriate antimicrobial therapy for patients.

Clinical Evidence

No clinical data provided. Performance data relies on the Bristol-Myers Squibb product insert for MAXIPIME® (Cefepime Hydrochloride) and adherence to established NCCLS M2-A5 and M100-S6 standards for antimicrobial susceptibility testing.

Technological Characteristics

High-quality paper discs impregnated with Cefepime (30 mcg content, marked FEP-30). Form factor: cartridges of 50 discs. Principle: agar diffusion (Bauer-Kirby method). Standards: NCCLS M2-A5 and M100-S6.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to cefepime in clinical isolates.

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

• Cefmetazole Sensi-Disc®

Submission Summary (Full Text)

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K961188

APR - 5 1996

Date 3/25/96

# 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:**
Cefepime Sensi-Discs
Catalog Numbers 31695, 31696

**Common Name/Description:**
Antimicrobial Susceptibility Test Discs

**Classification Name:**
Antimicrobial Susceptibility Test Discs

## PREDICATE DEVICE:

Other BBL® Sensi-Discs® such as
Cefmetazole 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. Cefepime Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including *Enterobacter* spp, *Escherichia coli*, *Klebsiella pneumoniae*, *Proteus mirabilis*, *Pseudomonas aeruginosa*, *Staphylococcus aureus* (methicillin-susceptible strains only), *Streptococcus pneumoniae*, and *Streptococcus pyogenes* (Lancefield’s Group A streptococci), to Cefepime. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Bristol-Myers Squibb, and received FDA approval under NDA No. 50-679.

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# INDICATIONS FOR USE:

Use of BBL® Cefepime Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to cefepime.

# PRODUCT DESCRIPTION:

Cefepime Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Cefepime supplied by the manufacturer, Bristol-Myers Squibb Company, Princeton, New Jersey. Each Cefepime disc is clearly marked on both sides with the agent and content (FEP-30). Cefepime discs are furnished in cartridges of 50 discs each. Cefepime 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 1940s. 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 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, GC II Agar with IsoVitaleX® Enrichment for N. gonorrhoeae 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

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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 Bristol-Myers Squibb Company product insert for MAXIPIME®, (Cefepime Hydrochloride) for Injection.

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