(76 days)
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No
The description explicitly states "manual reading procedures" and there are no mentions of AI, ML, image processing, or any data sets typically associated with training AI/ML models.
No
The device is for in vitro determination of antimicrobial susceptibility of bacteria, which is a diagnostic purpose, not a therapeutic one. It does not directly treat a disease or condition.
Yes
The device is used for the in vitro determination of antimicrobial susceptibility of bacteria, which is a diagnostic process to understand how effective an antimicrobial agent will be against a specific bacterial infection.
No
The device description explicitly states that the device "consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent," indicating a physical, hardware component.
Yes, based on the provided information, 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 a "quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria." The term "in vitro" is a key indicator of an IVD.
- Purpose: The device is used to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria, which is a diagnostic test performed outside of the living organism to assess its susceptibility to treatment.
- Testing Medium: The testing is performed on "agar media," which is a laboratory medium used for growing microorganisms, further confirming the in vitro nature of the test.
Therefore, the Liofilchem® MIC Test Strip (MTS) fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 the minibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Erythromycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.
Erythromycin has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:
Staphylococcus aureus
Product codes
JWY
Device Description
MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minibitory 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
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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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2017
LIOFILCHEM S. R. L. c/o LAURA KOETH PRESIDENT, LABORATORY SPECIALISTS, INC. 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145
Re: K172109
Trade/Device Name: Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256μg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: July 11, 2017 Received: July 13, 2017
Dear Ms. Koeth:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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Indications for Use
510(k) Number (if known) K172109
Device Name
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 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 the minibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Erythromycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.
Erythromycin has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:
Staphylococcus aureus
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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