(60 days)
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No
The description focuses on a paper strip with a concentration gradient and manual reading, with no mention of AI/ML or automated analysis.
No
This device is an in vitro diagnostic (IVD) tool used to determine antimicrobial susceptibility, which informs treatment decisions but does not directly provide therapeutic action.
Yes
Explanation: The device is intended for the "in vitro determination of antimicrobial susceptibility of bacteria," which is a diagnostic purpose to identify the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria. This information is crucial for guiding treatment decisions, which is a diagnostic function.
No
The device description explicitly states that the device "consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent," which is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "in vitro determination of antimicrobial susceptibility of bacteria." "In vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details a test strip used on agar media to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria. This is a classic example of an in vitro diagnostic test.
The purpose of the device is to analyze a sample (bacteria grown on agar) outside of the body to provide information about the susceptibility of those bacteria to a specific antimicrobial agent. This directly aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal susceptbility 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:
Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)
Gram-Negative bacteria Haemophilus influenzae
Product codes
JWY-Manual Antimicrobial Susceptibility Test Systems
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 (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font.
April 6, 2020
Liofilchem s. r. 1. % Anne Windau Supervisor Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145
Re: K200308
Trade/Device Name: MTS Lefamulin 0.016- 256 μg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY-Manual Antimicrobial Susceptibility Test Systems Dated: February 5, 2020 Received: February 6, 2020
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
1
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 mediation-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,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
MTS Lefamulin 0.016 - 256 ug/mL ==============================================================================================================================================
Indications for Use (Describe)
The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal susceptbility 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:
Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)
Gram-Negative bacteria Haemophilus influenzae
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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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