MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial 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 µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Imipenem at concentrations of 0.016 - 256 µg/mL should be interpreted at 16-20 hours of incubation.

Imipenem has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-negative bacteria

Citrobacter koseri Citrobacter freundii Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus vulgaris Providencia rettgeri Serratia marcescens Acinetobacter baumannii Pseudomonas aeruginosa

Imipenem has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

Gram-negative bacteria

Providencia stuartii

Device Description

AI/ML Overview

I am sorry, but the provided text does not contain the detailed study information I need to fulfill your request. The document is an FDA 510(k) clearance letter for the MTS Imipenem device, which indicates its intended use and lists bacterial species it's effective against. However, it does not include:

A table of actual acceptance criteria or reported device performance against those criteria.
Details about sample sizes for test sets, data provenance, or training sets.
Information on expert qualifications, ground truth establishment, or adjudication methods for studies.
Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 4, 2019

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

Re: K191908

Trade/Device Name: MTS Imipenem 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: July 15, 2019 Received: July 16, 2019

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. 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/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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Steven Gitterman. M.D., Ph.D. Deputy Director 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191908

Device Name

MTS Imipenem 0.016 - 256 µg/mL

Indications for Use (Describe)

MTS (MIC Test Stup) Imipenem 0.016 - 256 µg/mL is a quantitative method intended for the in virro determination of antimicrobial 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 (MC) in ughts against bacteria as tested on agar media using. overnight incubation and manual reading procedures. MTS Imipenem at concentrations of 0.016 - 256 ug/mL should be interpreted at 16-20 hours of incubation.

Imipenem has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-negative bacteria

Imipenem has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

Gram-negative bacteria

Providencia stuartii

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

Prescription Use (Part 21 CFR 801 Subpart D) X

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).