The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimiorobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/ml. o f antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Azithromycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.

Azithromycin has been shown to be active both clinically and in viro against the non-fastidious bacteria listed below according to the FDA label:

Staphylococcus aureus (including methicillin-resistant isolates)

Device Description

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/ml. o f antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

AI/ML Overview

This is an FDA 510(k) clearance letter for the Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL. This device is an antimicrobial susceptibility test and does not involve AI or human image interpretation. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the device, nor does it provide a direct table of "reported device performance" in the typical sense of sensitivity, specificity, or predictive values. Instead, the clearance is based on the device being "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" section indicates the intended performance:

Category	Description / Performance
Intended Use	Quantitative method for in vitro determination of antimicrobial susceptibility of bacteria.
Measurement	Determine Minimum Inhibitory Concentration (MIC) in µg/mL of antimicrobial agents against bacteria.
Incubation Period	16-20 hours of incubation.
Reading Procedure	Manual reading procedures.
Antimicrobial Agent	Azithromycin
Concentration Range	0.016-256 µg/mL
Active Against (Example)	Staphylococcus aureus (including methicillin-resistant isolates) - Note: The document states "Azithromycin has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label," but only Staphylococcus aureus is listed in the provided text snippet. This implies the device is intended to accurately measure susceptibility against this organism.*

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details about a specific "test set" sample size or data provenance. This information would typically be found in the 510(k) submission itself, which is not fully available here. The clearance letter only confirms that the FDA reviewed the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is for in vitro diagnostic testing, not for interpretation of medical images by human experts. The "ground truth" for antimicrobial susceptibility testing is typically established through reference methods (e.g., broth microdilution) rather than expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device. Adjudication methods are relevant for studies involving human interpretation of ambiguous data, which is not the case for this in vitro diagnostic.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an antimicrobial susceptibility test strip and does not involve AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical test strip that requires manual reading, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For antimicrobial susceptibility testing, the "ground truth" is typically established by comparing the device's results to a reference method (e.g., Clinical and Laboratory Standards Institute (CLSI) broth microdilution or agar dilution methods). The document does not explicitly state which reference method was used, but it is implied that such comparisons were part of the substantial equivalence determination.

8. The sample size for the training set

The document does not provide details about a "training set" or its sample size. This information would be specific to the development and validation studies within the 510(k) submission, not typically stated in the clearance letter.

9. How the ground truth for the training set was established

As above, details about a "training set" are not provided. For this type of device, if such a concept were applied, the ground truth would be established by reference methods.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 4, 2018

Liofilchem s. r. l. % Anne Windau General Supervisor Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145

Re: K180339

Trade/Device Name: Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: February 1, 2018 Received: February 7, 2018

Dear Anne Windau:

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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Ribhi Shawar -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number(if known)

K180339

Device Name

Liofilchem MIC Test Strip (MTS), Azithromycin 0.016-256 ug/mL

Indications for Use (Describe)

The Azithromycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.

Azithromycin has been shown to be active both clinically and in viro against the non-fastidious bacteria listed below according to the FDA label:

Staphylococcus aureus (including methicillin-resistant isolates)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).