(62 days)
The Liofilchem® MIC Test Strip (MTS) 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 inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Meropenen-vaborbactam MTS at concentrations of 0.016/8 - 2568 ug/mL should be interpreted at 16-20 hours of incubation.
Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:
Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae
Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms:
Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Proteus mirabilis Providencia spp. Serratia marcescens
MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The provided text describes the Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam, for determining antimicrobial susceptibility.
Here's a breakdown of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format. It refers to the device being "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards for antimicrobial susceptibility tests.
However, the "Indications for Use" section lists the active concentrations of Meropenem-vaborbactam (0.016/8 - 256/8 ug/mL) and specifies an incubation time of 16-20 hours. It also lists the bacteria against which the drug has shown activity, both clinically and in vitro.
Based on the provided text, a direct table of acceptance criteria and reported device performance cannot be generated as quantitative performance metrics are not included. The information focuses on regulatory approval and indications for use rather than detailed study results.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not include information about the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The provided text does not include information about the adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided text does not include information about whether an MRMC comparative effectiveness study was done or any effect sizes related to human reader improvement with AI assistance. This device is an antimicrobial susceptibility test strip, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The provided text describes the device as a "quantitative method" using a "specialized paper impregnated with a pre-defined concentration gradient" and "manual reading procedures." This indicates it is a standalone device without an algorithm in the typical sense of a software-based AI system, and its performance is inherently linked to manual interpretation. No information on an "algorithm only" performance study is present.
7. The Type of Ground Truth Used
The "Indications for Use" section states: "Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label..." and "Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms..."
This suggests that the ground truth relies on established clinical and in vitro activity data for Meropenem-vaborbactam against specific bacterial strains. This would typically involve microbiology laboratory gold standards for determining bacterial susceptibility (e.g., broth microdilution, agar dilution, or other validated reference methods).
8. The Sample Size for the Training Set
The provided text does not include information about the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not include information on how the ground truth for any training set was established. Given it's a quantitative method using a test strip for antimicrobial susceptibility, the "training" (if applicable, for method development) would likely involve comparison to established reference AST methods.
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December 19, 2017
Liofilchem s. r. 1. % Anne Windau Laboratory Specialists, Inc 1651-A Crossings Parkway Westlake, Ohio 44145
Re: K173307
Trade/Device Name: Lioffilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: October 17, 2017 Received: October 18, 2017
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
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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR 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 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.
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
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number if known)
Device Name
Liofilchem MIC Test Strip (MTS), Meropenem-vaborbactam 0.016/8 - 256/8 ug/mL
Indications for Use (Describe)
The Liofilchem® MIC Test Strip (MTS) 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 inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Meropenen-vaborbactam MTS at concentrations of 0.016/8 - 2568 ug/mL should be interpreted at 16-20 hours of incubation.
Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:
Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae
Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms:
Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Proteus mirabilis Providencia spp. Serratia marcescens
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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§ 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).