Search Results

E. faecalis PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is an FDA 510(k) clearance letter for the "E. faecalis PNA FISH" device, indicating its substantial equivalence to a predicate device.

The letter mentions the device's "Indications for Use" as a "qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures." However, it does not provide any specific information regarding:

1. Acceptance criteria
2. Reported device performance
3. Sample size, data provenance for the test set
4. Number/qualifications of experts for ground truth
5. Adjudication method
6. Multi-reader multi-case (MRMC) study results or effect size
7. Standalone performance
8. Type of ground truth used
9. Sample size for the training set
10. How the ground truth for the training set was established

These details would typically be found in the 510(k) submission summary or detailed study reports, which are not part of this clearance letter.

Ask a specific question about this device