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S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.

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

S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

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The provided document is a 510(k) clearance letter for the S. aureus PNA FISH® Culture Identification Kit. It does not contain the detailed study information regarding acceptance criteria and performance metrics. Substantial equivalence is determined by comparing the device to a legally marketed predicate device, but the specifics of the study design, sample sizes, expert qualifications, and ground truth establishment are not included within this regulatory letter.

Therefore, I cannot extract the requested information from this document.

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S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for presumptive identification of Staphylococcus aureus from blood cultures.

Not Found

This document is a 510(k) clearance letter for the S. aureus PNA FISH device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It mainly focuses on the regulatory aspects of the device's clearance.

Therefore, I cannot answer your request based on the provided text.

Ask a specific question about this device