HARDYDISK AST TELAVANCIN,30UG

K093807 · Hardy Diagnostics · JTN · Jan 8, 2010 · Microbiology

Device Facts

• Record ID: K093807
• Device Name: HARDYDISK AST TELAVANCIN,30UG
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Indications for Use

Use of HardyDisk™ Telavancin 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telavancin. The concentration of Telavancin 30 ug has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Methicillin-resistant staphylococci, streptococci, and vancomycinsusceptible enterococci.

Device Story

HardyDisk Telavancin 30 µg is an antimicrobial susceptibility test disc used in clinical microbiology laboratories. The device consists of a paper disc impregnated with 30 µg of the antibiotic telavancin. It is used in agar diffusion testing (Kirby-Bauer method) to determine the susceptibility of bacterial isolates to telavancin. The laboratory technician places the disc onto an agar plate inoculated with the patient's bacterial isolate. Following incubation, the zone of inhibition around the disc is measured. The size of the zone correlates with the susceptibility of the organism to the antibiotic, assisting clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

No clinical data required. Performance characteristics established via interpretive criteria and quality control ranges derived from CDER-approved pharmaceutical package inserts and clinical trial data evaluated during original drug approval (1794 patients with skin and skin structure infections).

Technological Characteristics

Paper disc impregnated with 30 µg of telavancin. Operates via agar diffusion principle. Class II medical device under 21 CFR 866.1620.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to telavancin. Active against Methicillin-resistant Staphylococci, Streptococci, and Vancomycin-susceptible Enterococci.

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.

Submission Summary (Full Text)

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

A. 510(k) Number:
K093807

B. Purpose for Submission:
To obtain a substantial equivalent determination for the Telavancin 30μg, Hardy Diagnostics™ Sensi-Disc™.

C. Measurand:
Susceptibility to Telavancin 30μg

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

E. Applicant:
Hardy Diagnostics

F. Proprietary and Established Names:
Hardy Disk μg Telavancin, 30μg

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JTN | II | 866.1620 | 83 Microbiology |

H. Intended Use:

1. Intended use(s):
Hardy Disk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp. Acinetobacter spp. Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae,

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N. meningitides and Streptococcus spp., including Streptococcus pneumoniae.

2. Indication(s) for use:

Use of Hardy Disk™ Telavancin 30μg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telavancin. The concentration of telavancin 30μg has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections.

Methicillin-resistant Staphylococci
Streptococci
Vancomycin- susceptible Enterococci

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

None

I. Device Description:

The Telavancin 30μg Hardy Disk™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk utilizes 6-mm disks prepared by impregnating absorbent paper with a known concentration. Each telavancin disk is marked on both sides with the agent (TLV) and drug content. (1) Cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing five cartridges.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Tigecycline 15μg, Hardy Disk™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk.

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

K062245

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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 pure isolated colonies using the direct inoculation method or growth method | same |
| Inoculation method | Directly equated to a 0.5 McFarland turbidity standard | same |

Difference

| Item | Device | Predicate |
| --- | --- | --- |
| Antibiotic | Telavancin | Tigecycline |
| Concentration | 30μg | 15μg |

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

CLSI M2-A9 "Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard." CLSI M100-S 16, "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:

HardyDisk™ utilizes 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 caution-adjusted Mueller-Hinton agar supplemented with the appropriate concentration of calcium. Four to five colonies are transferred to 5 ml of a suitable broth medium. The broth is incubated at 35-37°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 McFarland turbidity standard. The inoculum density may also be standardized

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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 disk dispenser or sterile forceps to ensure contact with the test surface. Plates are incubated in an ambient air incubator at 35-37°C. fastidious organisms (Streptococcus species) 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 telavancin approval, evaluated 1794 patients with skin and skin structure infections. This data was used to generate the Interpretive Criteria and QC Expected Ranges.

1. Analytical performance:

a. Precision/Reproducibility:
b. Linearity/assay reportable range:
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Q.C. isolates and the Expected Ranges are the same as recommended by the FDA/CDER in the approved pharmaceutical package insert.

d. Detection limit:
e. Analytical specificity:
f. Assay cut-off:

2. Comparison studies:

Not required for Antimicrobial Susceptibility Discs.

a. Method comparison with predicate device:
b. Matrix comparison:

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3. Clinical studies:

Not required for Antimicrobial Susceptibility Discs.

a. Clinical Sensitivity:
b. Clinical specificity:
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:

Staphylococcus aureus ≥15mm (S)*
Enterococcus faecalis (vancomycin-susceptible isolates only) ≥ 15mm (S)*
Streptococcus species other than S. pneumoniae ≥15mm (S)*

* The current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC or disk diffusion results suggestive of "Nonsusceptible" should be subjected to additional testing.

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.

N. Proposed Labeling:

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

O. Conclusion:

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