MEROPENEM, 10 MCG, SENSI-DISC

K963845 · Becton Dickinson Microbiology Systems · JTN · Oct 25, 1996 · Microbiology

Device Facts

• Record ID: K963845
• Device Name: MEROPENEM, 10 MCG, SENSI-DISC
• Applicant: Becton Dickinson Microbiology Systems
• Product Code: JTN · Microbiology
• Decision Date: Oct 25, 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. Meropenem Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Streptococcus peuemoniae (excluding penicillin-resistant strains), Viridans group streptococci, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteriodes thetaiotaomicron and peptostreptococcus species to Meropenem. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, ZENECA Pharmaceuticals, and received FDA approval under NDA No. 50-706.

Device Story

Meropenem Sensi-Discs consist of high-quality paper impregnated with specific concentrations of Meropenem. Used in clinical microbiology laboratories by technicians; discs are applied to the surface of inoculated agar plates (Mueller Hinton Agar, Haemophilus Test Medium, or Mueller Hinton with 5% Sheep Blood). Following incubation, the technician measures the diameter of the zone of inhibition surrounding the disc. These measurements are compared against established NCCLS zone size interpretive criteria to classify the organism as susceptible, intermediate, or resistant to Meropenem. This information assists healthcare providers in selecting appropriate antimicrobial therapy for patients.

Clinical Evidence

No clinical data; performance is based on established standardized agar diffusion procedures and interpretive criteria determined by the drug manufacturer (ZENECA Pharmaceuticals) under NDA 50-706, consistent with NCCLS M2-A5 and M100-S6 standards.

Technological Characteristics

High-quality paper discs impregnated with Meropenem; 10 mcg concentration. Standardized agar diffusion (Bauer-Kirby method). Manual application to agar plates. No electronic or software components.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to Meropenem. Applicable to gram-positive and gram-negative bacteria, including S. pneumoniae (excluding penicillin-resistant strains), Viridans group streptococci, E. coli, H. influenzae, K. pneumoniae, N. meningitidis, P. aeruginosa, B. fragilis, B. thetaiotaomicron, and peptostreptococcus species.

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

• Imipenem, 10 mcg, Sensi-Disc

Submission Summary (Full Text)

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OCT 25 1996
K963845

# ATTACHMENT A

Date 9/23/96

## SUMMARY OF SAFETY AND EFFECTIVENESS

### SUBMITTED BY:

Robert E. James, Director
International Regulatory and Quality Development
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville, MD 21030-0243

### NAME OF DEVICE:

Trade Name: Meropenem, 10 mcg, Sensi-Discs
Catalog Numbers 4331703, 4331704

Common Name/Description: Antimicrobial Susceptibility Test Discs

Classification Name: Antimicrobial Susceptibility Test Discs

### PREDICATE DEVICE:

Other BBL® Sensi-Discs® such as
Imipenem, 10 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. Meropenem Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including *Streptococcus peuemoniae* (excluding penicillin-resistant strains), Viridans group streptococci, *Escherichia coli*, *Haemophilus influenzae*, *Klebsiella pneumoniae*, *Neisseria meningitidis*, *Pseudomonas aeruginosa*, *Bacteroides fragilis*, *Bacteriodes thetaiotaomicron* and *peptostreptococcus* species to Meropenem. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, ZENECA Pharmaceuticals, and received FDA approval under NDA No. 50-706.

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# INDICATIONS FOR USE:

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

# PRODUCT DESCRIPTION:

Meropenem Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Meropenem supplied by the manufacturer, ZENECA Pharmaceuticals, Wilmington, Delaware. Each Meropenem disc is clearly marked on both sides with the agent and content. Meropenem discs are furnished in cartridges of 50 discs each. Meropenem 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* 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

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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 ZENECA Pharmaceuticals product insert section on Susceptibility testing Diffusion Techniques for Merrem® IV, (meropenem for Injection).

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