← Product Code [JTN](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN) · K152838

# HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 (K152838)

_Hardy Diagnostics · JTN · Nov 24, 2015 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K152838

## Device Facts

- **Applicant:** Hardy Diagnostics
- **Product Code:** [JTN](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN.md)
- **Decision Date:** Nov 24, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1620
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

Use of HardyDisk AST Ceftazidime/Avibactam, (30/20ug) - CZA50, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftazidime/Avibactam. The concentration of Ceftazidime/Avibactam, (30/20ug) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with in vitro use: Morganii, Providencia rettgeri, and Serratia marcescens. The concentration of Ceftazidime/Avibactam, (30/20ug) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with both in vitro and in clinical infections: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Citrobacter freundii, Citrobacter koseri, Proteus spp., and Enterobacter aerogenes.

## Device Story

HardyDisk AST Ceftazidime/Avibactam (30/20µg) is an antimicrobial susceptibility test disc used for in vitro agar diffusion testing. The device consists of a paper disc impregnated with a specific concentration of the antibiotic combination Ceftazidime/Avibactam. It is used in clinical microbiology laboratories by trained technicians to determine the susceptibility of bacterial isolates to the drug. The disc is placed on an inoculated agar plate; the antibiotic diffuses into the medium, creating a zone of inhibition around the disc. The diameter of this zone is measured and compared to established interpretive criteria to classify the bacteria as susceptible, intermediate, or resistant. This information assists clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

## Clinical Evidence

No clinical data. Performance characteristics rely on drug studies evaluated by FDA/CDER at the time of Ceftazidime/Avibactam pharmaceutical approval.

## Technological Characteristics

Antimicrobial susceptibility test disc impregnated with 30/20µg of Ceftazidime/Avibactam. Operates via passive diffusion of the antibiotic into agar medium. Standardized form factor for use in clinical microbiology laboratory workflows.

## Regulatory 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:
K152838

B. Purpose for Submission:
Addition of Ceftazidime/Avibactam Antimicrobial Susceptibility Test Disk

C. Measurand:
Ceftazidime/Avibactam, 30/20 µg

D. Type of Test:
Antimicrobial Susceptibility Test Disks

E. Applicant:
Hardy Diagnostics

F. Proprietary and Established Names:
HardyDisk AST Ceftazidime/Avibactam, (30/20µg)-CZA50

G. Regulatory Information:
1. Regulation section:
21 CFR 866.1620 Antimicrobial Susceptibility Test Disc
2. Classification:
Class II
3. Product code(s):
JTN - Susceptibility Test Disc, Antimicrobial
4. Panel:
83 - Microbiology

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H. Intended Use:

1. Intended use(s):

HardyDisk 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, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

2. Indication(s) for use:

Use of HardyDisk AST Ceftazidime/avibactam (30/20μg) – CZA50, for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftazidime/avibactam.

The concentration of Ceftazidime/Avibactam, (30/20μg)-CZA50, has been shown to be active against susceptible isolates of the following microorganism with in vitro use: Morganella morganii, Providencia rettgeri, and Serratia marcescens.

The concentration of Ceftazidime/Avibactam, (30/20μg)-CZA50, has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Citrobacter freundii, Citrobacter koseri, Proteus spp and Enterobacter aerogenes.

3. Special conditions for use statement(s):

Prescription use only

4. Special instrument requirements:

Not Applicable

I. Device Description:

HardyDisk™ AST Disks, utilize 6mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30μg Ceftazidime and 20μg Avibactam. The disks are marked with code CZA 50 on both sides. The letters CA are for the two agents and the number reflects the total content for both agents combined.

HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant.

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# J. Substantial Equivalence Information:

1. Predicate device name(s):

HardyDisk Tigecycline  $15\mu \mathrm{g}$

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

K062245

3. Comparison with predicate:

Table 1: Comparison with Predicate Device

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Test Method | Antimicrobial Susceptibility testing using paper discs impregnated with an antimicrobial agent | Same  |
|  Intended Use | Antimicrobial Susceptibility Test Disks are used for in vitro susceptibility testing by standardized agar diffusion test procedures. | Same  |
|  Methodology | Kirby-Bauer Disk Diffusion Susceptibility Test Protocol. Require the user to determine categorical interpretations (S/I/R) using the measured zone diameters. | Same  |
|  Inoculum Preparation | Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. | Same  |
|  Inoculum Method | Dip a sterile swab into the prepared inoculum, and streak an appropriate agar plate's surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the plate agar side up in a 35 +/- 2 degrees C. incubator for 18-24 hours. | Same  |
|  Interpretation | The user will interpret the zone diameters according established interpretive criteria for the drug | Same  |

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|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Product Name | HardyDisk AST
Ceftazidime/avibactam (30/20 μg)-
CZA50 | HardyDisk Tigecycline  |
|  Antibiotic | Ceftazidime-avibactam | Tigecycline  |
|  Concentration | 30μg Ceftazidime/20μg avibactam | 15μg  |

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

CLSI M02-A12. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Twelfth Edition

CLSI M100-S25. Performance Standards for Antimicrobial Susceptibility Testing; Approved Standard- Twenty-Fifth Informational Supplement.

## L. Test Principle:

The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with known concentrations of antimicrobial agents that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically.

Within 15 minutes of inoculum preparation, the Mueller Hinton agar is streaked with an inoculated swab to obtain an even inoculation. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16-18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO₂, as recommended in the CLSI M02 approved standard document.

After incubation the agar medium is examined for zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter 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 Ceftazidime/Avibactam disk. The drug studies evaluated by FDA/CDER at the time of Ceftazidime/Avibactam approval were used for review of this device.

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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
b. Clinical specificity:
Not Applicable

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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:

The Interpretative criteria are the same as recommended by the FDA/CDER in the approved pharmaceutical drug package insert.

Currently, there are no intermediate interpretative criteria for Ceftazidime/Avibactam.

Table 2. FDA Interpretive Criteria for Ceftazidime/Avibactam

|  Organism | Susceptibility Interpretive Criteria (Ceftazidime/Avibactam)  |   |   |
| --- | --- | --- | --- |
|   |  Disk Diffusion Zone Diameter (mm)  |   |   |
|   |  S | I | R  |
|  Enterobacteriaceae | ≥21 | - | ≤20  |
|  Pseudomonas aeruginosa | ≥18 | - | ≤17  |

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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K152838](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K152838)

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