(33 days)
The Liofilchem® MTS™ (MIC Test Strip) 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 concernment of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Plazoni.cin at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.
MTSTM PLZ can be used to determine the MC of plazomicin against the microorganisms listed in the table below:
Plazomicin Activity According to the FDA Label
Clinical and in vitro
Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis
in vitro only Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
MTS™ consists of specialized paper impregnated with a pre-defined concernment of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
This document describes the FDA 510(k) clearance for the Liofilchem MTS Plazomicin 0.016-256 ug/mL device, which is an antimicrobial susceptibility test. The information provided focuses on the regulatory clearance process rather than a detailed study demonstrating acceptance criteria and performance against an AI model.
Therefore, I cannot provide a response that directly addresses the user's request for:
- A table of acceptance criteria and reported device performance related to an AI model.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details specifically for an AI model.
The provided document describes a traditional in vitro diagnostic device, not an AI-powered one. The "acceptance criteria" discussed in the document are related to the substantial equivalence determination for regulatory clearance against a predicate device, and the "performance" refers to the ability of the MTS Plazomicin strips to accurately determine MICs of antimicrobial agents, as established by standard microbiological methods.
Based on the provided text, none of the requested information regarding AI model performance, studies, or ground truth establishment is available. The document is a 510(k) clearance letter for an antimicrobial susceptibility test strip, not a study report for an AI-powered diagnostic device.
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July 31, 2018
Liofilchem s. r. 1. % Laura Koeth President Laboratory Specialists, Inc. 26214 Center Ridge Road Westlake, Ohio 44145
Re: K181708
Trade/Device Name: MTS Plazomicin 0.016-256 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: June 27, 2018 Received: June 28, 2018
Dear Ms. Koeth:
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 comprehensive regulatory information about medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K181708
Device Name
MTSTM Plazomicin 0.016-256 ug/mL
Indications for Use (Describe)
The Liofilchem® MTS™ (MIC Test Strip) 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 concernment of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Plazoni.cin at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.
MTSTM PLZ can be used to determine the MC of plazomicin against the microorganisms listed in the table below:
Plazomicin Activity According to the FDA Label
Clinical and in vitro
Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis
in vitro only Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
Type of Use (Select one or both, as applicable)
O Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).