(68 days)
The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). 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 . teria as tested on agar media using overnight incubation and manual reading procedures.
The indications for use of this 510(k) is specifically for the Meropenen MTS at concentrations of 0.002-32 ug/mL.
The non-fastidious bacteria that have been shown to be active both clinically and in vitro against meropenem according to the FDA label are:
Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
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 . teria as tested on agar media using overnight incubation and manual reading procedures.
The provided text is a 510(k) premarket notification letter from the FDA to Liofilchem s.r.l., regarding their MIC Test Strip (MTS) for Meropenem. This document is a regulatory approval letter for an in-vitro diagnostic test for antimicrobial susceptibility, not for an AI/ML-driven medical device.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria for an AI/ML device: The device is a physical test strip, not an algorithm.
- Study proving device meets acceptance criteria (for an AI/ML device): The "performance" in this context refers to the accuracy of the antimicrobial susceptibility test in determining MIC, not the performance of an AI/ML model.
- Sample size for test set, data provenance: Not relevant for this type of device approval.
- Number of experts, qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size or ground truth establishment: These are all concepts specific to the development and validation of AI/ML algorithms, which are not applicable to the Liofilchem MIC Test Strip.
To summarize, the provided text is about the regulatory approval of a traditional in-vitro diagnostic device and does not offer any details pertinent to the development and validation of an AI/ML-based medical device.
§ 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).