(43 days)
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No
The description focuses on a paper strip impregnated with an antimicrobial agent for manual reading of bacterial susceptibility, with no mention of AI/ML or automated analysis.
No.
This device is an in vitro diagnostic (IVD) tool used to determine the antimicrobial susceptibility of bacteria, specifically the minimum inhibitory concentration (MIC) of gentamicin. It is not applied directly to a patient for treatment.
Yes
The device is described as a "quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria," which determines the minimum inhibitory concentration (MIC) of antimicrobial agents. This helps assess how well bacteria respond to certain drugs, which is a key diagnostic step in determining appropriate treatment strategies.
No
The device description explicitly states that the device consists of "specialized paper impregnated with a pre-defined 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 / Indications for Use" section explicitly states that the device is "intended for the in vitro determination of antimicrobial susceptibility of bacteria." The term "in vitro" means "in glass" or "outside of a living organism," which is a key characteristic of IVDs.
- Purpose: The device is used to determine the minimum inhibitory concentration (MIC) of an antimicrobial agent against bacteria. This is a diagnostic test performed on a sample (bacteria grown on agar media) to provide information about the susceptibility of the bacteria to a specific drug.
- Method: The method involves testing the bacteria on agar media and using a specialized paper strip impregnated with the antimicrobial agent. This is a laboratory-based test, typical of IVDs.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body or other sources to provide information for the diagnosis, treatment, or prevention of disease. In this case, the information is about the susceptibility of bacteria to an antibiotic, which is crucial for guiding treatment decisions.
N/A
Intended Use / Indications for Use
The MTS (MIC Test Strip) Gentamicin 0.016-256 ug/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 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.
MTS Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation.
MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin 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 freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens
Product codes
JWY
Device Description
MTS consists of specialized paper impregnated with a pre-defined 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
Not Found
§ 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).
0
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March 22, 2019
Liofilchem s. r. l. % Anne Windau Supervisor Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145
Re: K190252
Trade/Device Name: MTS Gentamicin 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: February 6, 2019 Received: February 7, 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
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/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,
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
2
Indications for Use
510(k) Number (if known) K190252
Device Name
MTS Gentamicin 0.016-256 µg/mL
Indications for Use (Describe)
The MTS (MIC Test Strip) Gentamicin 0.016-256 ug/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 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.
MTS Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation.
MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin 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 freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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