TELITHROMYCIN 15UG BBL SENSI-DISC

K052876 · Becton, Dickinson & CO · JTN · Nov 14, 2005 · Microbiology

Device Facts

• Record ID: K052876
• Device Name: TELITHROMYCIN 15UG BBL SENSI-DISC
• Applicant: Becton, Dickinson & CO
• Product Code: JTN · Microbiology
• Decision Date: Nov 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Indications for Use

Telithromycin 15 µg BBL™ Sensi-Disc™ are intended for use 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

Device consists of paper disks impregnated with 15µg telithromycin; used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing via agar diffusion (Bauer-Kirby method). Disks applied to inoculated Mueller Hinton Agar (or specialized media for specific organisms); plates incubated; zones of inhibition measured. Healthcare providers compare zone diameters against established CLSI/NCCLS standards to categorize isolates as susceptible, intermediate, or resistant. Results guide antimicrobial therapy selection for patients with bacterial infections. Benefits include standardized, reliable determination of antibiotic susceptibility to inform clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on established standardized agar diffusion methodology and performance standards defined by CLSI/NCCLS and FDA-approved drug inserts.

Technological Characteristics

Impregnated paper disks; 15µg telithromycin concentration. Principle: Agar diffusion (Bauer-Kirby). Media: Mueller Hinton Agar, Haemophilus Test Medium Agar, or Mueller Hinton Agar with 5% Sheep Blood. Manual measurement of inhibition zones. No software, electronics, or energy source.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to telithromycin. Target organisms include Staphylococcus aureus (methicillin and erythromycin susceptible), Streptococcus pneumoniae (including multi-drug resistant), Haemophilus influenzae, Streptococcus pyogenes (erythromycin susceptible), Streptococci (groups C and G), and Viridans group streptococci. For prescription use only.

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

• Ciprofloxacin 5 µg, BBL™ Sensi-Disc™

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K052876

B. Purpose for Submission:
Introduction of the antibiotic Telithromycin 15 µg BBL™ Sensi-Disc™

C. Measurand:
Telithromycin 15 µg

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

E. Applicant:
Becton Dickinson and Company, BD Diagnostic Systems

F. Proprietary and Established Names:
Telithromycin 15 µg BBL™ Sensi-Disc™

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

H. Intended Use:

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1. Intended use(s):

Telithromycin 15 µg BBL™ Sensi-Disc™ are intended for use 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:

Telithromycin 15 µg BBL™ Sensi-Disc™ are indicated for *in vitro* agar diffusion susceptibility testing when there is a need to determine the susceptibility of bacteria to telithromycin. The concentration of telithromycin 15 µg has been shown to be active *in vitro* against most strains of the microorganisms listed: *Staphylococcus aureus* (methicillin and erythromycin susceptible only), *Streptococcus pneumoniae* (including multi-drug resistant isolates), *Haemophilus influenzae*, *Streptococcus pyogenes* (erythromycin susceptible isolates only), *Streptococci* (Lancefield groups C and G) and Viridans group streptococci.

3. Special conditions for use statement(s):

The ability of the Telithromycin 15 µg BBL™ Sensi-Disc™ to detect resistance with Staphylococcus aureus (methicillin and erythromycin susceptible isolates only) is unknown because these strains have not yet been detected and should be retested. If the non-susceptible result is obtained the strain should be sent to a reference laboratory for further testing.

For prescription use only.

4. Special instrument requirements:

None

I. Device Description:

Telithromycin 15 µg BBL™ Sensi-Disc™ utilizes 6-mm disks prepared by impregnating absorbent paper with a known concentration of telithromycin. Disks are marked on both sides with letters and numbers designating the agent and the drug concentration. Sensi-Disc™ agents are furnished in cartridges containing 50 disks each.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Ciprofloxacin

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

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K874425

# 3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | An in vitro diagnostic product for clinical susceptibility testing of aerobic gram positive and gram negative bacteria | same |
| Inoculum | Prepared from colonies using the direct inoculation method or growth method | same |
| Inoculation method | Direct equated to a 0.5 McFarland turbidity standard | same |
| Difference | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Antibiotic | telithromycin | ciprofloxacin |

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

CLSI/NCCLS M7 (M100-S15) "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard". 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:

$\mathrm{BBL}^{\mathrm{TM}}$ Sensi-Disc™ utilize dried filter paper disks impregnated with known concentrations of antimicrobial agents that are placed onto the test medium surface. The standard method of testing is the Kirby-Bauer method. The recommended test medium is cation-adjusted Mueller-Hinton agar supplemented with the appropriate concentration of calcium. Four to five colonies are transferred to $5\mathrm{ml}$ of a suitable broth medium. The broth is incubated at $35 - 37^{\circ}\mathrm{C}$ for 2 to 8 hours until a light to moderate turbidity develops. Alternately, a direct broth or saline suspension of colonies may be prepared from an 18-24 hour agar plate culture. The final inoculum density should be equivalent to a $0.5\mathrm{McFarland}$ turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller-Hinton agar is streaked to obtain an even inoculation. Disks are aseptically placed onto the agar surface with a disc dispenser or sterile forceps to ensure contact with the test surface. Plates are

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incubated in an ambient air incubator at 35-37° C. Fastidious organisms (Haemophilus spp., Neisseria gonorrhoeae and some Streptococcus pneumoniae) are tested using appropriate media incubated in a CO₂ enriched atmosphere, as recommended in the CLSI M7 Approved Standard document. After incubation the media is examined, and zones of inhibition around the disks are measured and compared against recognized zone size ranges for the antimicrobial agent being tested.

## M. Performance Characteristics (if/when applicable):

Descriptive characteristics were sufficient for this disk, because the drug studies, evaluated by CDER at the time of telithromycin approval, generated the Interpretive Criteria and QC Expected Ranges.

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

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3. Clinical studies:

a. Clinical Sensitivity:
Not applicable

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 in millimeters:
Staphylococcus aureus >=22 (S)*
Streptococcus pneumoniae >=19 (S), 16-18 (I), <=15 (R)
Haemophilus species >=15 (S), 12-14 (I), <=11 (R)

N. Proposed Labeling:

The Interpretive Criteria, Q.C. isolates and the 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. The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

*The current absence of data on Methicillin Susceptible Staphylococcus aureus resistant strains precludes defining any results other than "Susceptible". Strains yielding results suggestive of a "non-susceptible" category should be submitted to a reference laboratory for further testing.

O. Conclusion:

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