HARDYDISK AST DORIPENEM 10 UG

K080019 · Hardy Diagnostics · JTN · Jan 29, 2008 · Microbiology

Device Facts

• Record ID: K080019
• Device Name: HARDYDISK AST DORIPENEM 10 UG
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Jan 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

HardyDisk™ Antimicrobial Susceptibility Test 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 procedure, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis, and Streptococcus spp., including Streptococcus pneumoniae.

Device Story

HardyDisk™ Doripenem 10μg consists of 6-mm absorbent paper disks impregnated with Doripenem; used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing via Kirby-Bauer agar diffusion method. Laboratory technicians place disks onto inoculated Mueller-Hinton agar plates; plates incubated at 35-37°C. After incubation, technicians measure zones of inhibition around disks; compare measurements against established interpretive criteria to determine bacterial susceptibility. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. Device provides standardized method for assessing drug activity against specific pathogens.

Clinical Evidence

No clinical diagnostic studies required. Interpretive criteria and quality control ranges were derived from CDER-reviewed multi-center clinical outcome studies involving 2,117 patients (946 with complicated intra-abdominal infections; 1,171 with complicated urinary tract infections) conducted for the drug approval process.

Technological Characteristics

6-mm absorbent paper disks impregnated with 10μg Doripenem. Principle: Kirby-Bauer agar diffusion. Requires cation-adjusted Mueller-Hinton agar. Manual measurement of inhibition zones. No electronic or software components.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing of bacteria to Doripenem. Patient population includes those with infections caused by Acinetobacter baumannii, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Streptococcus constellatus, and Streptococcus intermedius. 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

• HardyDisk™ Tigecycline (K062245)

Submission Summary (Full Text)

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

A. 510(k) Number:
K080019

B. Purpose for Submission:
To obtain a substantial equivalent determination for the Doripenem 10μg HardyDisk™

C. Measurand:
Susceptibility to Doripenem 10μg

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

E. Applicant:
Hardy Diagnostics

F. Proprietary and Established Names:
HardyDisk™ Doripenem 10μg

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):
HardyDisk™ Antimicrobial Susceptibility Test 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 procedure, *Haemophilus* spp., *Neisseria gonorrhoeae*, *N. meningitidis*, and *Streptococcus* spp., including *Streptococcus pneumoniae*.

2. Indication(s) for use:
Use of HardyDisk™ Doripenem 10μg for *in vitro* agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Doripenem. The concentration of Doripenem 10μg has been shown to be active against most isolates of the following microorganisms:

Both *in vitro* and in clinical infections:
*Acinetobacter baumannii*, *Escherichia coli*, *Klebsiella pneumoniae*, *Proteus mirabilis*, *Pseudomonas aeruginosa*, *Streptococcus constellatus*, *Streptococcus intermedius*.

3. Special conditions for use statement(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.

For prescription use only.

4. Special instrument requirements:
None

I. Device Description:
The HardyDisk™ Doripenem 10μg utilizes 6-mm disks prepared by impregnating absorbent paper with a known concentration of Doripenem. Disks are marked on both sides with letters (DOC) and numbers (10) designating the agent and the drug content. HardyDisk™ are furnished in cartridges containing 50 disks each.

J. Substantial Equivalence Information:

1. Predicate device name(s):
HardyDisk™ Tigecycline

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

K062245

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 | Directly equated to a 0.5 McFarland turbidity standard | same |
| Difference | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Antibiotic | Doripenem | Tigecycline |

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

CLSI M2-A9 "Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard." CLSI M100-S17, "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 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

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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 disk dispenser or sterile forceps to ensure contact with the test surface. Plates are incubated in an ambient air incubator at $35 - 37^{\circ}\mathrm{C}$. Fastidious organisms (*Streptococcus species*) are tested using appropriate media incubated in a $\mathrm{CO}_{2}$ 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 are sufficient for susceptibility test discs, because the drug manufacturer performed several clinical outcome studies enrolling 2117 patients, which were evaluated by CDER to grant approval of doripenem. These studies generated the Interpretive Criteria and QC Expected Ranges which the susceptibility tests disc manufactures use for interpretation of results also. No additional *in vitro* diagnostic clinical studies are therefore required.

### 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 required—CDER reviewed data from a multi-center double-blinded study of 946 adults with complicated intra-abdominal infections and 1171 adults with complicated urinary tract infections to determine not only drug efficacy, but also interpretative criteria and quality control ranges.
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:
Pseudomonas aeruginosa ≥ 24mm (S)*
Acinetobacter baumannii ≥ 17mm (S)*
Streptococcus anginosus group ≥ 24mm (S)*
Enterobacteriaceae ≥ 23 mm (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.

N. Proposed Labeling:

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

O. Conclusion:

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

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