(63 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Gatifloxacin in the dilution range of 0.002 - 8 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Gatifloxacin is for: Haemophilus Influenzae
Not Found
The document is a 510(k) premarket notification for the addition of Gatifloxacin to Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. It primarily discusses the regulatory approval process and does not contain detailed information about a study that would provide acceptance criteria and device performance metrics in the format requested.
Therefore, I cannot extract the specific information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance information.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).