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Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain.

Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.

Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay

This document is a 510(k) clearance letter for the Enterococcus QuickFISH BC device. It does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The letter primarily covers:

• The FDA's determination of substantial equivalence for the device.
• Regulatory information regarding the device's classification and applicable regulations.
• The intended use statement for the device.

Therefore, I cannot provide the requested information based on the provided text. The document acts as an approval notice, not a detailed performance study report.

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E. faecalis/OE PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures containing Grampositive cocci in pairs and chains observed on Gram stain.

Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "E. faecalis PNA FISH® Culture Identification Kit". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for information about acceptance criteria and supporting studies based on the provided text.

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Ask a specific question about this device

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.

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