(51 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for Sulbactam in the dilution range of 0.015/4-32/4 ug/mL for testing non-fasidious Gram negative organisms on the Sensititre 18 - 24 hour MIC panel.
Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Acinetobacter baumannii-calcoaceticus complex
Not Found
This is a 510(k) clearance letter for an antimicrobial susceptibility test (AST) system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices. The document is a regulatory approval for a laboratory diagnostic product, specifically for testing the susceptibility of certain bacteria to a new antibiotic combination (Sulbactam-durlobactam).
The type of "performance" for such a device is related to its accuracy in determining minimum inhibitory concentrations (MICs) or breakpoints, and its ability to correctly classify bacteria as susceptible, intermediate, or resistant to the antibiotic.
Here's how I can address your request based on the provided text, while also noting what is not present:
A. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or a detailed performance table for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam.
For this type of device (Antimicrobial Susceptibility Test), acceptance criteria typically involve:
- Essential Agreement (EA): The percentage of MIC values that are within ±1 doubling dilution of a reference method.
- Category Agreement (CA): The percentage of isolates that are categorized identically (Susceptible, Intermediate, or Resistant) by the test system and the reference method.
- Major Errors (ME): When the test system reports an isolate as Susceptible when the reference method reports it as Resistant.
- Very Major Errors (VME): When the test system reports an isolate as Resistant when the reference method reports it as Susceptible.
Regulatory guidance for AST devices usually sets specific thresholds for these metrics (e.g., >90% EA, >90% CA,
§ 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).