(60 days)
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.
Not Found
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.
§ 866.3700
Staphylococcus aureus serological reagents.(a)
Identification. Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genusStaphylococcus and provides epidemiological information on these diseases. Certain strains ofStaphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.