(125 days)
S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
S. aureus/CNS 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 from the FDA for a diagnostic kit, not a study report. It does not contain the detailed information required to fulfill the request. The document clears the S. aureus and/or other Staphylococcus species PNA FISH® Culture Identification Kit based on its substantial equivalence to predicate devices, but it does not describe the specific acceptance criteria or the study that proves the device meets those criteria in the level of detail requested.
Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case study details, standalone performance, ground truth types, or training set information.
The document only states the Indications for Use:
- Identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.
- Intended as an aid in the diagnosis of S. aureus bacteremia.
It also explicitly states: "Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth." This implies the device is an identification aid, not a complete diagnostic solution for resistance or mixed infections.
§ 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.