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, Staphylococus 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 Eravacycline 2015 (ERV20) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria among the Enterobacteriaceae to Eravacycline.

HardyDisk AST Eravacycline at concentration 20μg can be used to determine the zone diameter (mm) of Eravacycline against the following bacteria among the Enterobacteriaceae.

Eravacycline has been shown to be active both clinically and in vitro against the following organisms: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Eravacycline has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the HardyDisk AST Eravacycline 20ug (ERV20) device, which is an antimicrobial susceptibility test disc. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the specific acceptance criteria, study details, or performance data that would allow me to populate the requested table and answer the study-related questions. The document mentions "Performance Studies Microbiologist" and "reviewed your Section 510(k) premarket notification," implying that studies were conducted and reviewed by the FDA, but the details of those studies are not present in this regulatory letter itself.

Therefore, I cannot provide a complete answer to your request based solely on the provided text. To answer your questions, I would need access to the actual 510(k) summary or the full submission which would contain the performance data and study design.

If the information were available, here's how I would structure the answer:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Essential Agreement (EA)	(e.g., ≥90% for categorical agreement with reference method)	(e.g., XX% for Enterobacteriaceae)
Categorical Agreement (CA)	(e.g., ≥90% for categorical agreement with reference method)	(e.g., YY% for Enterobacteriaceae)
Minor Discrepancies	(e.g., ≤Z% for minor errors)	(e.g., A% for minor errors)
Major Discrepancies	(e.g., ≤B% for major errors)	(e.g., C% for major errors)
Very Major Discrepancies	(e.g., ≤D% for very major errors)	(e.g., E% for very major errors)

2. Sample Size and Data Provenance

Test Set Sample Size: [Number of isolates tested, broken down by organism if applicable]
Data Provenance: [e.g., Multi-center clinical trial in the United States and Europe, retrospective collection from various clinical labs, prospective study]

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: [Number, e.g., 2]
Qualifications of Experts: [e.g., Clinical microbiologists with >10 years of experience in antimicrobial susceptibility testing, board-certified pathologists.]

4. Adjudication Method

Adjudication Method: [e.g., Not applicable as ground truth was established by a single reference method (e.g., broth microdilution), or if there were discrepancies, a third expert reviewed, 2+1, 3+1, etc.]

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. (Based on the nature of this device, a diagnostic test for bacterial susceptibility, MRMC studies are not typically performed. These are more common for imaging devices where human interpretation is a key component.)
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone Performance Study

Standalone Study Done? Yes. (The performance of the HardyDisk AST Eravacycline 20ug is inherently a standalone performance evaluation of the disc's ability to produce accurate zone diameters compared to a reference method.)

7. Type of Ground Truth Used

Ground Truth Type: Reference broth microdilution method (e.g., CLSI standard M07 or equivalent), which is the gold standard for determining minimum inhibitory concentrations (MICs).

8. Sample Size for Training Set

Training Set Sample Size: [Not applicable for this type of device, as it is a physical disc and not an AI/ML algorithm that requires a training set. If it were a software algorithm, this would be a crucial detail.]

9. How Ground Truth for Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

September 26, 2018

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

Re: K182357

Trade/Device Name: HardyDisk AST Eravacycline 20ug (ERV20) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: Class II Product Code: JTN Dated: August 29, 2018 Received: August 30, 2018

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Steven R. Gitterman -S for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182357

Device Name HardyDiskTM AST Eravacycline 20ug (ERV20)

Indications for Use (Describe)

HardyDisk AST Eravacycline at concentration 20μg can be used to determine the zone diameter (mm) of Eravacycline against the following bacteria among the Enterobacteriaceae.

Eravacycline has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 866.1620 Antimicrobial susceptibility test disc.

(a)
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.(b)
Classification. Class II (performance standards).