FLUCONAZOLE 25UG BBL SENSI-DISC

K082271 · Becton, Dickinson & CO · JTN · Oct 6, 2008 · Microbiology

Device Facts

• Record ID: K082271
• Device Name: FLUCONAZOLE 25UG BBL SENSI-DISC
• Applicant: Becton, Dickinson & CO
• Product Code: JTN · Microbiology
• Decision Date: Oct 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

BBL™ Sensi-Disc™ Fluconazole Antimicrobial Susceptibility Discs are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of fungal pathogens. Use of Fluconazole 25 ug, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Fluconazole. The concentration of 25 ug has been shown to be active in vitro against most strains of Candida albicans, Candida glabrata (many strains are intermediately susceptible), Candida parapsilosis, and Candid tropicalis. For prescription use only. Isolates of C. krusei are assumed to be intrinsically resistant to fluconazole and their zone diameters should not be interpreted using the FDA interpretive criteria.

Device Story

Fluconazole 25 µg BBL™ Sensi-Disc™ consists of high-quality paper disks impregnated with a specific concentration of fluconazole. Used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing of fungal pathogens. The operator places disks onto Mueller Hinton Agar plates inoculated with pure cultures of clinical isolates. Following incubation, the operator measures the diameter of the zone of inhibition surrounding the disk. These measurements are compared against established interpretive criteria (zone size ranges) provided in the FDA-approved pharmaceutical package insert to categorize the organism as susceptible, intermediate (or susceptible-dose dependent), or resistant. This information assists healthcare providers in selecting appropriate antifungal therapy for patients.

Clinical Evidence

No clinical data. The device relies on interpretive criteria and quality control ranges established by the FDA/CDER through pharmaceutical clinical trials for fluconazole.

Technological Characteristics

Paper disks impregnated with 25 µg fluconazole. Principle: Agar disc diffusion (Kirby-Bauer method). Form factor: Cartridges of 50 disks. No electronic components, software, or energy source.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine pathogen susceptibility to Fluconazole. Active against Candida species including C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. dubliniensis, C. guilliermondii, C. kefyr, and C. lusitaniae.

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

• BBL™ Sensi-Disc™ Antimicrobial Susceptibility test Disks, Ciprofloxacin 5 μg (k874425)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k082271

B. Purpose for Submission:
Addition of Fluconazole to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disc

C. Measurand:
Fluconazole 25 µg

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

E. Applicant:
BD Diagnostic Systems

F. Proprietary and Established Names:
Fluconazole 25 ug BBL™ Sensi-Disc™

G. Regulatory Information:
1. Regulation section:
21 CFR 866.1620
2. Classification:
II
3. Product code:
JTN Susceptibility Test Disc, Antimicrobial
4. Panel:

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83 Microbiology

## H. Intended Use:

### 1. Intended use(s):

BBL™ Sensi-Disc™ Fluconazole Antimicrobial Susceptibility Discs are used for semi-quantitative *in vitro* susceptibility testing by the agar disc diffusion test procedure of fungal pathogens.

### 2. Indication(s) for use:

Use of Fluconazole 25 ug, BBL™ Sensi-Disc™ for *in vitro* agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Fluconazole. The concentration of 25 ug has been shown to be active *in vitro* against most strains of *Candida albicans*, *Candida glabrata* (many strains are intermediately susceptible), *Candida parapsilosis*, and *Candid tropicalis*.

### 3. Special conditions for use statement(s):

For prescription use only

Isolates of *C. krusei* are assumed to be intrinsically resistant to fluconazole and their zone diameters should not be interpreted using the FDA interpretive criteria.

### 4. Special instrument requirements:

Not Applicable

## I. Device Description:

Fluconazole 25 ug BBL™ Sensi-Disc™ is prepared by impregnating high quality paper accurately with determined amounts of Fluconazole supplied by the drug manufacturer. Each Fluconazole disk is clearly marked on both sides with the agent and drug content. Fluconazole cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Fluconazole 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):

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BBL™ Sensi-Disc™ Antimicrobial Susceptibility test Disks, Ciprofloxacin 5 μg

2. Predicate K number(s):

k874425

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 1. Intended Use | test susceptibility to pathogenic isolates | same |
| 2. Inoculum | pure colonies | same |
| 3. Results | minimum inhibitory concentration (MIC) results based on measurements of zone diameters | |
| 3. Interpretation | categorical interpretations (S-I-R) using the measured zone diameters | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 1. Test organisms | fungi | bacteria |
| 2. Antibiotic | fluconazole 25 μg | ciprofloxacin 5 μg |

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

Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Informational Supplement M44-S2; The Center for Drug, Evaluation, and Review (CDER) pharmaceutical approved package insert, developed during clinical trial studies, was used for Interpretive Criteria and Quality Control (QC) expected ranges.

# L. Test Principle:

Disks containing a wide variety of selected agents are applied to the surface of Mueller Hinton Agar plates, supplemented as needed and inoculated with pure culture 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 agents in order to determine the agent(s) most suitable for use in therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested is made by comparing zone diameters to those found in the approved pharmaceutical package insert.

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M. Performance Characteristics (if/when applicable): (Descriptive characteristics were sufficient for this disc, because the drug studies that CDER evaluated generated the Interpretive Criteria and Quality Control (QC) Expected Ranges used for review of this device.)

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Not Applicable
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable

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b. Clinical specificity:

Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not Applicable

4. Clinical cut-off:

Not Applicable

5. Expected values/Reference range:

| | Disk Diffusion at 24 hours (Zone Diameters in mm) | | |
| --- | --- | --- | --- |
| Antimicrobial Agent | Susceptible (S) | Intermediate (I)** | Resistant (R) |
| Fluconazole* | ≥19 | 15 – 18 | ≤14 |
| | | | |

* Isolates of C. krusei are assumed to be intrinsically resistant to fluconazole and their MICs and/or zone diameters should not be interpreted using this scale.

** The intermediate category is sometimes called Susceptible-Dose Dependent (SDD) and both categories are equivalent for fluconazole.

# N. Proposed Labeling:

The Interpretative criteria, QC isolates and expected ranges are the same as recommended by the FDA/CDER in the approved pharmaceutical package insert. All values will be included in the device package insert.

# O. Conclusion:

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