(185 days)
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.
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(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 § 866.9.