(61 days)
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No
The description details a manual method using impregnated paper strips and visual interpretation, with no mention of automated analysis, algorithms, or machine learning.
No
The device is an in vitro diagnostic (IVD) tool used to determine the minimum inhibitory concentration of antimicrobial agents against bacteria, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for "in vitro determination of antimicrobial susceptibility of bacteria," which is a diagnostic process to identify the effectiveness of antimicrobial agents against specific bacteria.
No
The device description explicitly states it consists of "specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent," indicating a physical, hardware component.
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." "In vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Purpose: The device is used to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria. This is a diagnostic test used to guide treatment decisions for bacterial infections.
- Method: The description details a laboratory method involving testing bacteria on agar media.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
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 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 Tedizolid MTS at concentrations of 0.002- 32 ug/mL should be interpreted at 16-20 hours of incubation for nonfastidious organisms and 20-24 hours for fastidious organisms.
Tedizolid has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA drug label:
Staphylococcus aureus (including methicillin resistant and methicillin susceptible isolates) Enterococcus faecalis
Tedizolid has been shown to be active both climically and in vitro against the fastidious bacteria listed below according to the FDA drug label:
Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. constellatus, S. intermedius)
Product codes
JWY
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2017
LIOFILCHEM S. R. L. C/O LAURA KOETH PRESIDENT, LABORATORY SPECIALISTS, INC. 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145
Re: K172542
Trade/Device Name: Liofilchem MIC Test Strip (MTS) - Tedizolid 0.002 - 32μg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: August 22, 2017 Received: August 24, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172542
Device Name
Liofilchem MIC Test Strip (MTS), Tedizolid 0.002-32 µg/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 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 Tedizolid MTS at concentrations of 0.002- 32 ug/mL should be interpreted at 16-20 hours of incubation for nonfastidious organisms and 20-24 hours for fastidious organisms.
Tedizolid has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA drug label:
Staphylococcus aureus (including methicillin resistant and methicillin susceptible isolates) Enterococcus faecalis
Tedizolid has been shown to be active both climically and in vitro against the fastidious bacteria listed below according to the FDA drug label:
Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. constellatus, S. intermedius)
| 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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