(268 days)
The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.
The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp.
This 510(k) is for the addition of: "Sensititre® OptiRead™"
The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.
The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.
The provided text is a 510(k) summary from the FDA for a medical device called Sensititre® OptiRead™. It discusses the regulatory approval, but it does not contain the specific detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more extensive 510(k) submission.
Here's a breakdown of why I cannot fulfill your request based solely on the provided text, and what kind of information would be needed:
- This document is a regulatory approval letter, not a study report. It confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not detail the technical performance studies in depth.
To answer your request comprehensively, I would need a different type of document, such as:
- The full 510(k) submission: This would contain the study protocols, results, and acceptance criteria.
- A clinical study report or technical file: These documents detail the performance evaluation of the device.
Therefore, based on the provided text, I cannot furnish the requested information.
What I can infer from the provided text, which hints at the device's function and purpose, is:
- Device Name: Sensititre® OptiRead™
- Intended Use: To be used with the Sensititre® MIC or BP Susceptibility Test System. It is a fluorescence-based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for clinical susceptibility testing of non-fastidious Gram positive cocci (Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae, and other Streptococcus spp.). Results are transferred to SWIN software for generation.
- Regulatory Clearance: K103532, cleared on August 26, 2011.
To illustrate what you would generally expect to find if the information were present, here's how a hypothetical response might look if the data were available in the document:
Hypothetical Response (if the information were available in the document):
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (e.g., % Agreement vs. Predicate) | Reported Device Performance (Sensititre® OptiRead™) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% | 97.2% |
| Category Agreement (CA) | ≥ 90% | 98.5% |
| Major Discrepancies (MD) | ≤ 3.0% | 1.2% |
| Very Major Discrepancies (VMD) | ≤ 1.5% | 0.5% |
| Minor Discrepancies | Not exceeding [specific threshold] | [specific percentage] |
| Time to Result | Comparable to predicate (e.g., within X minutes) | Matches manual reading time |
| Fluorescence Readout Reproducibility | CV |
§ 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).