(99 days)
Not Found
It looks like the text you provided does not contain the information needed to answer the question. The "Reference Device(s)" section explicitly states "Not Found".
No
The device description and intended use clearly state that the method involves manual reading procedures and overnight incubation, with no mention of automated analysis or AI/ML technologies. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is an in vitro diagnostic (IVD) tool designed to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria. It is used for diagnostic purposes (to assess susceptibility), not to directly treat or prevent a disease in a patient.
Yes
The device is intended for the in vitro determination of antimicrobial susceptibility, which is a diagnostic purpose to identify how effective an antimicrobial agent is against specific bacteria, aiding in treatment decisions.
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." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Purpose: The purpose of the 510(k) submission is for a specific version of the device used for "in vitro determination of antimicrobial susceptibility."
- Device Description: The device description details how the device is used to test bacteria on agar media, which is a laboratory procedure performed outside of the body.
All of these points clearly indicate that the device is designed for diagnostic testing performed in a laboratory setting, which is 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 suscretibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example. Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, Haemophilus and Streptococcus species and N. gonorrhoeae). 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 up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 us/mL interpreted after 24 hours incubation.
The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are:
Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium
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
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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.)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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, with flowing lines above them.
April 1, 2016
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
LIOFILCHEM S.R.L. % LAURA KOETH LABORATORY SPECIALISTS, INC. 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145
Re: K153687
Trade/Device Name: Liofilchem MIC Test Strip (MTS)-Vancomvcin 0.016 -256 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY Dated: December 16, 2015 Received: January 14, 2016
Dear Ms. Koeth:
This letter corrects our substantially equivalent letter of March 31, 2016.
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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
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) K153687
Device Name
Liofilchem MIC Test Strip (MTS) - Vancomycin 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 suscretibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example. Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, Haemophilus and Streptococcus species and N. gonorrhoeae). 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 up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 us/mL interpreted after 24 hours incubation.
The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are:
Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium
| 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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