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

Indications for 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) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K050062

B. Purpose for Submission:
Premarket notification to add gemifloxacin to the BBL Sensi-Disc product line

C. Measurand:
Gemifloxacin 5μg/mL

D. Type of Test:
Semi-quantitative Antimicrobial Susceptibility Test Disc

E. Applicant:
Becton Dickinson and Company

F. Proprietary and Established Names:
Gemifloxacin 5μg, BBL Sensi-Disc Antimicrobial Susceptibility Test Disks

G. Regulatory Information:

1. Regulation section:
866.1620 Antimicrobial Susceptibility Test Disc

2. Classification:
II

3. Product code:
JTN- Susceptibility Test Disc, Antimicrobial

4. Panel:
83 Microbiology

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H. Intended Use:

1. Intended use(s):

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.

2. Indication(s) for use:

Use of Gemifloxacin 5 µg, BBL Sensi-Disc for *in vitro* agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to gemifloxacin. 5 µg has been shown to be active *in vitro* 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:
- *Streptococcus pneumoniae* (including multi-drug resistant strains)
- *Haemophilus influenzae*
- *Haemophilus parainfluenzae*
- *Klebsiella pneumoniae* (many strains are only moderately susceptible)

Active *In Vitro* against:
- *Staphylococcus aureus* (methicillin-susceptible strains only)
- *Streptococcus pyogenes*
- *Acinetobacter lwoffii*
- *Klebsiella oxytoca*
- *Proteus vulgaris*

3. Special conditions for use statement(s):

Gemifloxacin exhibits *in vitro* minimal inhibitory concentrations of 0.25 µg/mL or less against most (> 90%) strains of the following microorganisms; however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and well controlled clinical trials: *Staphylococcus aureus* (methicillin-susceptible strains only), *Streptococcus pyogenes*, *Acinetobacter lwoffii*, *Klebsiella oxytoca*, *Proteus vulgaris*.

For *Streptococcus pneumoniae*, use Mueller-Hinton Agar with 5% Sheep Blood. For *Haemophilus influenzae* use Haemophilus Test Medium Agar.

For Prescription Use only.

4. Special instrument requirements:

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None

I. 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 (GEM) and drug content (5 μg). Gemifloxacin cartridges each contain 50 impregnated disks that are paced as either a single cartridge in 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.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Ciprofloxacin 5μg, BBL Sensi-Disc

2. Predicate 510(k) number(s):

K874425

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms. | same |
| Inoculum | Pure cultures of bacterial isolates | same |
| Inoculation method | Direct equated to a 0.5 McFarland | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Antibiotic | Gemifloxacin | Ciprofloxacin |

K. Standard/Guidance Document Referenced (if applicable):

The Center for Drug Evaluation and Review (CDER) pharmaceutical approved package insert, developed during clinical trial studies, was used for Interpretive Criteria and QC expected Ranges.

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L. Test 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 (Bauer-Kirby method). 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”).

M. Performance Characteristics (if/when applicable):

(Descriptive characteristics were sufficient for this disc, because the drug studies, evaluated by CDER, generated the Interpretive Criteria and QC expected Ranges used for review of this device.)

1. Analytical performance:

a. Precision/Reproducibility:
Not applicable (N/A)

b. Linearity/assay reportable range:
N/A

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
N/A

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:

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N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical Sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a. and b. are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
Enterobacteriaceae ≥ 20 (S), 16-19 (I), ≤ 15 (R)
Streptococcus pneumoniae ≥ 23 (S), 20-22 (I), ≤ 19 (R)
Haemophilus spp. ≥ 18 (S)

The Interpretative criteria in the manufacturer's instructions for use are the same as recommended by the FDA/CDER in the approved pharmaceutical package insert. The manufacturer's QC isolates and ranges also match the approved pharmaceutical package insert but also include QC ranges for *P. aeruginosa* or *S. aureus* that are absent from the pharmaceutical package insert but match what is recommended by NCCLS. All values will be included in the device package insert.

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For some organism/antimicrobial combinations, the absence of data on resistant strains precludes defining any results other than "Susceptible". Strains yielding MIC results suggestive of a "non-susceptible" category should be submitted to a reference laboratory for further testing.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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