HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170127 B. Purpose for Submission: Addition of Ceftolozane/Tazobactam Antimicrobial Susceptibility Test Disk for testing Enterobacteriaceae C. Measurand: Ceftolozane/Tazobactam, 30/10μg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk Ceftolozane/Tazobactam, (30/10μg) - C/T40 G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN – Susceptibility Test Disc, Antimicrobial 4. Panel: 83 - Microbiology {1} 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 Ceftolozane/Tazobactam, (30/10μg) - C/T40, for *in vitro* agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam. The concentration of Ceftolozane/Tazobactam, (30/10μg) - C/T40, has been shown to be active against susceptible isolates of the following microorganisms with *in vitro* use: *Citrobacter koseri*, *Morganella morganii*, *Proteus vulgaris*, *Providencia rettgeri*, *Providencia stuartii*, *Serratia liquefaciens*, and *Serratia marcescens*. The concentration of Ceftolozane/Tazobactam, (30/10μg)-C/T40, has been shown to be active against susceptible isolates of the following microorganisms both *in vitro* and in clinical infections: *Enterobacter cloacae*, *Escherichia coli*, *Klebsiella oxytoca*, *Klebsiella pneumoniae*, *Proteus mirabilis*, and *Pseudomonas aeruginosa*. 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*. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not Applicable {2} # I. Device Description: The HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of $30\mu \mathrm{g}$ Ceftolozane and $10\mu \mathrm{g}$ of Tazobactam. The disks are marked with the code C/T40 on both sides. The letters C/T 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. # 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: HardyDisk Ceftolozane/Tazobactam K170127 | Predicate: HardyDisk Tigecycline K062245 | | 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 | {3} | Similarities | | | | --- | --- | --- | | Item | Device: HardyDisk Ceftolozane/Tazobactam K170127 | Predicate: HardyDisk Tigecycline K062245 | | Inoculum | Prepared from pure isolated colonies in a suspension to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. | Same | | Inoculum Method | A sterile swab is dipped into the prepared inoculum, and applied to the surface of an appropriate agar plate in three directions. Disks impregnated with the antimicrobial agent are added to the surface of the plate. The plate is incubated agar side up in a 35 ± 2°C incubator for 18-24 hours. | Same | | Interpretation | The user will interpret the zone diameters according established interpretive criteria for the drug. | Same | | Differences | | | | Item | Device | Predicate | | Product Name | HardyDisk Ceftolozane/Tazobactam (30/10μg)- C/T40 | HardyDisk Tigecycline | | Antibiotic | Ceftolozane/Tazobactam | Tigecycline | | Concentration | 30μg Ceftolozane/10μg Tazobactam | 15μg Tigecycline | # 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; Twenty-Fifth Informational Supplement # L. Test Principle: The HardyDisk AST Disks are 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 $4 - 5\mathrm{mL}$ of a suitable broth medium. The broth is incubated at $35^{\circ}\mathrm{C}$ for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. {4} 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 $35 \pm 2^{\circ}\mathrm{C}$ for 16 -18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with $5\%$ $\mathrm{CO}_{2}$, 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 Ceftolozane/Tazobactam disk. The studies evaluated by FDA/CDER at the time of Ceftolozane/Tazobactam approval were used for this review. ### 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: {5} 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 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: Table 2: FDA Interpretative Criteria for Ceftolozane/Tazobactam | Indications For Use Organism(s) | Interpretative Criteria | | | | --- | --- | --- | --- | | | Zone Diameter (mm) | | | | | R | I | S | | Enterobacteriaceae | ≤17 | 18-20 | ≥21 | 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.