(56 days)
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No
The description details a manual, in vitro antimicrobial susceptibility test using paper strips with a concentration gradient, read visually after incubation. There is no mention of automated analysis, algorithms, or any technology that would suggest AI/ML is involved.
No
This device is an in vitro diagnostic (IVD) tool for determining antimicrobial susceptibility, not a therapeutic device used for treating diseases or conditions.
Yes
This device is intended for the in vitro determination of antimicrobial susceptibility of bacteria to determine the minimum inhibitory concentration (MIC), which is a diagnostic function as it identifies if a bacterium is susceptible or resistant to an antimicrobial agent.
No
The device description explicitly states it is a "specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent," indicating a physical, hardware component.
Based on the provided text, 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" is a key indicator of an IVD.
- Function: The device is used to determine the minimum inhibitory concentration (MIC) of an antimicrobial agent against bacteria, which is a common diagnostic test performed outside of the living body.
- Testing on Agar Media: The description mentions testing "on agar media," which is a standard laboratory technique for growing and testing bacteria in a controlled environment, outside of a patient.
Therefore, the device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MTS (MIC Test Strip) Omadacycline 0.002 - 32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTSTM consists of specialized paper impregated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum infortory concentration (MC) in ugimL of antimicrobial agents agamst bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 ugimL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:
Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus anginosus group (includes S. anginosus and S. constellatus) Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Haemophilus influenzae Haemophilus parainfluenzae
Omalacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label:
Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii
Citrohacter koseri lebstella aerogenes
Product codes
JWY-Manual Antimicrobial Susceptibility Test Systems
Device Description
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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
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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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2020
Liofilchem s. r. 1. % Anne Windau Supervisor Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145
Re: K200180
Trade/Device Name: MTS Omadacycline 0.002 - 32 µg/mL Regulation Number: 21 CFR 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY-Manual Antimicrobial Susceptibility Test Systems Dated: January 22, 2020 Received: January 24, 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 medical devices and radiation-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 Omadacycline 0.002 - 32 µg/mL
Indications for Use (Describe)
The MTS (MIC Test Strip) Omadacycline 0.002 - 32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTSTM consists of specialized paper impregated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum infortory concentration (MC) in ugimL of antimicrobial agents agamst bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 ugimL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:
Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus anginosus group (includes S. anginosus and S. constellatus) Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Haemophilus influenzae Haemophilus parainfluenzae
Omalacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label:
Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii
Citrohacter koseri lebstella aerogenes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) X
Over-The-Counter Use (21 CFR 801 Subpart C)
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