(41 days)
MTSTM (MIC Test Strip) Levofloxacin 0.002-32 ug/mL is a quantitative method intended for the in viro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.
MTS™ Levofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation.
MTSTM Levofloxacin can be used to determine the MIC of levofloxacin against the following bacteria.
Levofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria
Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Levofloxacin 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 Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii
MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.
The provided text is a 510(k) clearance letter from the FDA for a device called "MTS™ Levofloxacin 0.002-32 µg/mL." This device is an antimicrobial susceptibility test (AST) and determines the minimum inhibitory concentration (MIC) of levofloxacin against certain bacteria.
This document does NOT contain information about an AI/ML-driven medical device or any study that would typically involve acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC). It describes a traditional in-vitro diagnostic (IVD) device for antimicrobial susceptibility testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert consensus, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. These concepts are not applicable to the information contained in this 510(k) clearance.
The "study that proves the device meets the acceptance criteria" in the context of this document would refer to the analytical and clinical performance studies conducted by the manufacturer (Liofilchem s.r.l.) to demonstrate that their MTS™ Levofloxacin device is substantially equivalent to a legally marketed predicate device. This typically involves:
- Analytical Performance: Studies to show the accurate and precise determination of MIC values (e.g., reproducibility, precision, linearity).
- Clinical Performance: Studies to demonstrate agreement between the MTS™ Levofloxacin device and a reference method (e.g., broth microdilution) in determining the susceptibility of bacterial isolates to levofloxacin. This generally falls into categories like:
- Essential Agreement (EA): The percentage of isolates for which the MIC value obtained by the test device is within ±1 doubling dilution of the reference method.
- Categoryical Agreement (CA): The percentage of isolates for which the susceptibility category (susceptible, intermediate, resistant) determined by the test device matches that of the reference method.
- Major Discrepancies (MD): When the reference method classifies an isolate as susceptible and the test device classifies it as resistant.
- Very Major Discrepancies (VMD): When the reference method classifies an isolate as resistant and the test device classifies it as susceptible.
The acceptance criteria for such an IVD device are typically based on established CLSI (Clinical and Laboratory Standards Institute) guidelines or similar regulatory standards for AST devices, focusing on acceptable rates of agreement and low rates of discrepancies.
In summary, the provided text does not describe an AI medical device; therefore, an answer fitting the requested format for such a device cannot be generated from this document.
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December 20, 2018
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Liofilchem s. r. l. % Anne Windau Supervisor Laboratory Specialists. Inc. 26214 Center Ridge Road Westlake, Ohio 44145
Re: K183115
Trade/Device Name: MTS Levofloxacin 0.002 - 32 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: November 8, 2018 Received: November 9, 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. 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,
Uwe Scherf -S
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)
Device Name
MTS™ Levofloxacin 0.002-32 µg/mL
Indications for Use (Describe)
MTSTM (MIC Test Strip) Levofloxacin 0.002-32 ug/mL is a quantitative method intended for the in viro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.
MTS™ Levofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation.
MTSTM Levofloxacin can be used to determine the MIC of levofloxacin against the following bacteria.
Levofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria
Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Levofloxacin 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 Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii
| 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).