HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

K191931 · Hardy Diagnostics · JTN · Jul 31, 2019 · Microbiology

Device Facts

• Record ID: K191931
• Device Name: HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Jul 31, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

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. Use of HardyDisk AST Imipenem/Relebactam 10/25μg (IMR10/25) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of bacteria to Imipenem/Relebactam. HardyDisk AST Imipenem/Relebactam at concentration 10/25μg can be used to determine the zone diameter (mm) of Imipenem/Relebactam against the following bacteria for which Imipenem/Relebactam has been shown to be active both clinically and in vitro: Citrobacter freundii, Klebsiella aerogenes, Klebsiella oxytoca, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Imipenem/Relebactam has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri and Enterobacter asburiae.

Device Story

HardyDisk AST Imipenem/relebactam 10/25ug (IMR 10/25) is an antimicrobial susceptibility test (AST) disc used for in vitro diagnostic testing. The device is used by clinical microbiology laboratories to determine the susceptibility of bacteria to the antimicrobial agent imipenem/relebactam. The disc is placed on inoculated agar media; as the antibiotic diffuses into the medium, it creates a zone of inhibition around the disc. The diameter of this zone is measured and compared to established interpretive criteria to categorize the organism 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 is supported by analytical data from microbiology disk studies evaluated by CDER, including disk-to-MIC correlation studies and quality control testing conducted in accordance with CDER guidance for systemic antibacterial drugs.

Technological Characteristics

Antimicrobial susceptibility test disc containing 10ug imipenem and 25ug relebactam. The device functions via passive diffusion of the antimicrobial agent into agar media to inhibit bacterial growth. It is a standalone, non-electronic, single-use diagnostic consumable.

Indications for Use

Indicated for semi-quantitative in vitro susceptibility testing of rapidly growing and fastidious bacteria, specifically Citrobacter freundii, Klebsiella aerogenes, Klebsiella oxytoca, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Also includes Citrobacter koseri and Enterobacter asburiae (clinical significance unknown).

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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July 31, 2019

Hardy Diagnostics Anna Klavins Lead Performance Studies Microbiologist 1430 West McCoy Lane Santa Maria, California 93455

## Re: K191931

Trade/Device Name: HardyDisk AST Imipenem/relebactam 10/25ug (IMR 10/25) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: July 18, 2019 Received: July 19, 2019

## Dear Anna Klavins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure