(75 days)
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No
The description focuses on a manual, paper-based method for determining antimicrobial susceptibility with overnight incubation and manual reading. There is no mention of automated analysis, image processing, or any terms related to AI/ML.
No
This device is for in vitro determination of antimicrobial susceptibility of bacteria, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria, specifically used to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against bacteria. This process of identifying the susceptibility of bacteria to drugs is a form of diagnosis, as it determines a characteristic state relevant to treatment.
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." The term "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 help determine the appropriate treatment for bacterial infections.
- Sample Type: The test is performed on bacteria grown on agar media, which are biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring or compatibility purposes. While the text doesn't explicitly state the specimens are from the human body, the context of testing antimicrobial susceptibility of bacteria strongly implies this is for diagnosing and treating human infections.
N/A
Intended Use / Indications for Use
The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimiorobial 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 (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Ceftazidime-avibactam MTS at concentrations of 0.016/4- 2564 ug/mL should be interpreted at 16-20 hours of incubation.
Ceftazidime-avibactam has been shown to be active both clinically and in viro against the non-fastidious bacteria listed below
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available but their clinical significance is unknown:
Citrobacter koseri Enterobacter aerogenes Providencia stuartii
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.)
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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 contains 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.
February 28, 2018
Liofilchem s. r. l. % Laura Koeth President Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145
Re: K173817
Trade/Device Name: Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 μg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: December 13, 2017 Received: December 15, 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 Part 801 and Part 809); medical device 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
1
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 mediation-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
510(k) Number(if known)
Device Name
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4-256/4 ug/mL
Indications for Use (Describe)
The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimiorobial 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 (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Ceftazidime-avibactam MTS at concentrations of 0.016/4- 2564 ug/mL should be interpreted at 16-20 hours of incubation.
Ceftazidime-avibactam has been shown to be active both clinically and in viro against the non-fastidious bacteria listed below
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available but their clinical significance is unknown:
Citrobacter koseri Enterobacter aerogenes Providencia stuartii
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)
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