(84 days)
For in vitro diagnostic use: System U3 is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation. This 510(k) application is for System U3/Nitrofurantoin susceptibility testing based on the MIC breakpoints of Susceptible 5 32 yylml, Intermediate 64 ug/ml and Resistant ≥ 120 ug/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria from urines only.
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This document is a 510(k) clearance letter from the FDA for a device called "System U3TM for Nitrofurantoin." It describes its intended use for antimicrobial susceptibility testing. The provided text does not contain the detailed information needed to answer the specific questions about acceptance criteria and study design elements you've requested.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to an existing approved device that it doesn't need to undergo the more rigorous premarket approval process.
To gain insights into the acceptance criteria and the study that proves the device meets them, you would typically need to refer to the original 510(k) submission itself (K983562), which would contain a comprehensive description of the device, its performance data, and the comparison to the predicate device.
Therefore,Based on the provided text, I cannot extract the information required to populate the fields you requested. The document is a 510(k) marketing clearance letter, not a performance study report.
Here's why and what's missing:
- Acceptance Criteria and Reported Device Performance: This letter only states "substantially equivalent" to predicate devices. It doesn't detail performance metrics or specific acceptance criteria met by the System U3.
- Sample Size, Data Provenance, Expert Information, Adjudication: These are all details of the study that would have been submitted in the 510(k) to demonstrate substantial equivalence, but are not present in this clearance letter.
- MRMC study, Standalone performance: These types of studies would be described in the 510(k) submission, not summarized in the clearance letter.
- Ground Truth Type, Training Set Size, Training Set Ground Truth: Similar to above, these are elements of a detailed study report that are not included in this document.
To get answers to your questions, you would need to access the full 510(k) submission for K983562, which would contain the performance data and study details that the FDA reviewed to make its substantial equivalence determination.
§ 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).