(75 days)
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
MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent
The provided text describes the Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 μg/mL, which is a quantitative method for in vitro determination of antimicrobial susceptibility of bacteria. The document is a 510(k) clearance letter from the FDA, and it outlines the indications for use and general regulatory information. However, it does not contain the specific detailed information for acceptance criteria and the study that proves the device meets those criteria, such as specific performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or adjudication methods.
Therefore, many of the requested details cannot be extracted directly from this document. I will provide what can be inferred or stated as "not found" based on the given text.
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a specific table of acceptance criteria and reported device performance metrics (e.g., categorical agreement, essential agreement, accuracy, sensitivity, specificity values). The document indicates that the device has been found substantially equivalent to predicate devices, implying that it meets regulatory expectations for antimicrobial susceptibility testing, but the numerical performance data are not included.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Implied: Demonstrate substantial equivalence to predicate devices for antimicrobial susceptibility determination. | Device is cleared for marketing, suggesting performance is acceptable to FDA. |
| Implied: Accurate determination of MICs for listed bacteria. | Device determines MIC in μg/mL against specified bacteria (Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, etc.). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not found in the provided text. The document refers to "in vitro data" but doesn't specify the details of the test set, sample size, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not found in the provided text. As this is an in-vitro diagnostic device for antimicrobial susceptibility, the "ground truth" would typically be established by a reference method (e.g., broth microdilution or agar dilution) rather than human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not found in the provided text. Adjudication methods are typically relevant for image-based diagnostic systems where human interpretation is involved. For an antimicrobial susceptibility test, the "adjudication" would involve comparing the MTS results to a reference method according to predefined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not found in the provided text. The device described is an in-vitro diagnostic test strip that is manually read, not an AI-assisted diagnostic system involving human readers. Therefore, an MRMC study or AI assistance effect size is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "MIC Test Strip" which is "used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures." This indicates that human-in-the-loop performance is a fundamental part of the device's intended use. A standalone algorithm performance would not be relevant or possible for this type of manual test strip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the ground truth method. However, for antimicrobial susceptibility testing, the ground truth is typically established by a recognized reference method, such as:
- CLSI (Clinical and Laboratory Standards Institute) recommended reference broth microdilution or agar dilution methods.
8. The sample size for the training set
This information is not found in the provided text. This document is a 510(k) clearance letter, which typically summarizes the regulatory decision rather than detailed study protocols or training set specifics.
9. How the ground truth for the training set was established
This information is not found in the provided text. Similar to point 8, the detailed methodology for establishing ground truth for any presumed training set (if applicable for test strip development) is not included in this regulatory letter. It's likely that if a "training set" in a machine learning sense were applicable, the ground truth would be established by reference methods as described in point 7.
{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)
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
"An 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."
§ 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).