(62 days)
Not Found
Not Found
No
The description details a manual, paper-based method for determining antimicrobial susceptibility, with no mention of automated analysis, image processing, or any terms related to AI/ML.
No
This device is an in vitro diagnostic (IVD) tool used to determine the antimicrobial susceptibility of bacteria, not to treat a condition or disease in a patient.
Yes
The device determines the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria, which is used to assess antimicrobial susceptibility. This information is crucial for guiding treatment decisions and is a form of in vitro diagnostic testing.
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 to assess how effectively an antibiotic will work against a specific bacterial infection.
- Sample Type: The test is performed on bacteria grown on agar media, which is a laboratory sample, not a sample taken directly from a patient's body for immediate analysis within the body.
Therefore, based on the provided text, the Liofilchem® MIC Test Strip (MTS) clearly 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 inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Meropenen-vaborbactam MTS at concentrations of 0.016/8 - 2568 ug/mL should be interpreted at 16-20 hours of incubation.
Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:
Enterobacter cloacae species complex
Escherichia coli
Klebsiella pneumoniae
Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms:
Citrobacter freundii
Citrobacter koseri
Enterobacter aerogenes
Klebsiella oxytoca
Proteus mirabilis
Providencia spp.
Serratia marcescens
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 inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2017
Liofilchem s. r. 1. % Anne Windau Laboratory Specialists, Inc 1651-A Crossings Parkway Westlake, Ohio 44145
Re: K173307
Trade/Device Name: Lioffilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: October 17, 2017 Received: October 18, 2017
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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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.
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)
Device Name
Liofilchem MIC Test Strip (MTS), Meropenem-vaborbactam 0.016/8 - 256/8 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 inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Meropenen-vaborbactam MTS at concentrations of 0.016/8 - 2568 ug/mL should be interpreted at 16-20 hours of incubation.
Meropenem-vaborbactam has been shown to be active both clinically and in vitro against the non-fastidious bacteria listed below according to the FDA label:
Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae
Meropenem/vaborbactam has been shown to be active in vitro against susceptible isolates of the following microorganisms:
Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Proteus mirabilis Providencia spp. Serratia marcescens
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"Afl agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."