GEMIFLOXACIN, 5UG BBL SENSI-DISC

K050062 · Becton, Dickinson & CO · JTN · Feb 10, 2005 · Microbiology

Device Facts

• Record ID: K050062
• Device Name: GEMIFLOXACIN, 5UG BBL SENSI-DISC
• Applicant: Becton, Dickinson & CO
• Product Code: JTN · Microbiology
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

These discs are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. These include the Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Enterococcus spp., Vibrio cholerae and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae, Streptococcus pneumoniae and other streptococci.

Device Story

Gemifloxacin 5μg BBL Sensi-Disc consists of paper disks impregnated with gemifloxacin. Used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing via agar disk diffusion (Bauer-Kirby method). Disks are placed on inoculated agar plates; following incubation, zones of inhibition are measured. Zone diameters are compared against established NCCLS/FDA interpretive criteria to categorize bacterial isolates as susceptible, intermediate, or resistant. Results assist clinicians in selecting appropriate antimicrobial therapy. Benefits include standardized assessment of bacterial susceptibility to gemifloxacin.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and adherence to standardized agar diffusion methodology as described in the Gemifloxacin drug package insert.

Technological Characteristics

Paper disks impregnated with 5μg gemifloxacin. Principle: Agar disk diffusion (Bauer-Kirby). Requires Mueller-Hinton Agar (or variants with 5% Sheep Blood or Haemophilus Test Medium). Manual measurement of inhibition zones. Standards: NCCLS M2 and M100.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to gemifloxacin. Patient population includes those with infections caused by S. pneumoniae, H. influenzae, H. parainfluenzae, K. pneumoniae, S. aureus (methicillin-susceptible), S. pyogenes, A. lwoffii, K. oxytoca, and P. vulgaris.

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

• Other BBL™ Sensi-Disc™ (eg. Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)

Submission Summary (Full Text)

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510(k) Submission

Gemifloxacin 5ug BBL Sensi-Disc

# FEB ] 0 2005

| Date: February 1, 2005 | 510(k) SUMMARY |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Becton Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone [phone]<br>Fax: [phone] |
| CONTACT NAME: | Bradford M. Spring, Manager, Regulatory Affairs |
| DATE PREPARED: | February 1, 2005 |
| DEVICE TRADE NAME: | GEMIFLOXACIN 5µg, BBL™ Sensi-Disc™ Antimicrobial<br>Susceptibility Test Disks |
| DEVICE COMMON NAME: | Antimicrobial Susceptibility Test Disks |
| DEVICE CLASSIFICATION: | 21 CFR§866.1620, Class II (Product Code JTN),<br>Susceptibility Test Disks, Antimicrobial |
| PREDICATE DEVICE: | Other BBL™ Sensi-Disc™<br>(eg. Ciprofloxacin 5 µg, BBL™ Sensi-Disc™) |

#### INTENDED USE:

Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility Alltimicroulal Susceptionity Fest Disks are asceller some quality of ug BBL" Sensi-Disc" is testing of claims. In determining the susceptibility to Gemifloxacin of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-158.

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## DEVICE DESCRIPTION:

Gemifloxacin 5μg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Gemifloxacin supplied by the drug manufacturer. Each Gemifloxacin disk is clearly marked on both sides with the agent and drug content. Gemifloxacin cartridges each contain 50 impregnated disks that are packed as either a single Gemifloxatin a single box, or in a package containing ten cartridges. Gemifloxacin disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper disks impregnated with Agar anradientrations of antimicrobial agents were developed in the 1940s. In order to specifications 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.

## DEVICE PRINCIPLE:

Disks containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the disks 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 categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of NCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests) and of NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").

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# DEVICE COMPARISON:

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Gemifloxacin 5μg is similar to the BBL" Sensi-Disc " Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:

- Both methods are for antimicrobial susceptibility testing using paper disks impregnated with . an antimicrobial agent.
- Both methods have the same intended use. .
- Both methods provide the user with antimicrobic minimum inhibitory concentration (MIC) . results based on measurements of zone diameters.
- Both methods require the user to determine categorical interpretations (S/I/R) using the . measured zone diameters against NCCLS Approved Standards M2 and M100.
- Both methods use pure cultures of bacterial isolates. .

The BBL " Sensi-Disc " Antimicrobial Susceptibility Test Disks - Gemifloxacin 5μg differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:

- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks Gemifloxacin 5μg is a . susceptibility test that uses disks impregnated with the antimicrobic Gemifloxacin at a concentration of 5ug while the BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks -Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 ug.
- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk Gemifloxacin 5 µg is a . susceptibility test used to test a different battery of microorganisms than the BBL " Sensi-Disc Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 ug.

# SUBSTANTIAL EQUIVALENCE TESTING DATA:

See the Gemifloxacin drug package insert, "Susceptibility Tests: Diffusion Techniques".

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 1 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bradford M. Spring Manager, Regulatory Affairs BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

k050062 Re:

K050062
Trade/Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Gemifloxacin 5 ug

Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disks Regulatory Class: Class II Product Code: JTN Dated: January 5, 2005 Received: January 11, 2005

Dear Mr. Spring:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1978, tire excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costicule 710- (110-) that as nevice, subject to the general controls provisions of the Act. The r ou may, mercrore, mainer and a ct include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (660 ace +6) trols. Existing major regulations affecting your device It may be subject to subil additions come regulations (CFR), Parts 800 to 895. In addition, FDA ean be found in Ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Driver and inat your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I cuttar statutes and regulaments, including, but not limited to: registration and listing (21 compry with an the 1100 beep Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you w ough finding of substantial equivalence of your device to a legally promation in the results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific information and advertising of your device, please contact the Office of In of quostions on the prome Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally, a Horr

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K050062

Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Gemifloxacin 5ug

### Indications for Use:

Use of Gemifloxacin 5μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is a indicated when there is a need to determine the susceptibility of bacteria to Gemifloxacin. 5µg Indicated when there in a need witro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

#### Active In Vitro and in clinical infections against:

Aerobic gram-positive microorganisms Acrobic Erail pneumoniae (including multidrug resistant strains) Aerobic gram-negative microorganisms Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae (many strains are only moderately susceptible)

Active In Vitro Against:

Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pyogenes

Aerobic gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Fuddite. Cook

vision Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) KD50062

Becton, Dickinson and Company

February 1, 2005