(223 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 moxifloxacin in the dilution range of 0.008-16 µg/mL for testing non-fastidious gram-positive isolates on the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Staphylococcus spp. and Enterococcus faecalis, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms:
- Staphylococcus spp. (S. aureus, S. epidermidis, S. haemolyticus, S. hominis, S. lugdunensis, and S. saprophyticus)
- Enterococcus faecalis
Not Found
I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain the detailed information necessary to answer your request. The letter confirms the clearance of the device and its intended use, but it does not include any information regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or specific performance data (such as a table of described acceptance criteria vs. reported device performance, MRMC studies, or standalone algorithm performance).
The letter is a regulatory document stating that the device is "substantially equivalent" to predicate devices, which means it meets the safety and effectiveness requirements for marketing. However, it does not provide the underlying study details that led to this determination.
To answer your questions, I would need access to the actual study reports or summaries submitted by Thermo Fisher Scientific to the FDA, which are not present in this clearance letter.
§ 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).