(241 days)
The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.
The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with the MIDI Sherlock® Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.
The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.
I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The text is a 510(k) clearance letter for the MIDI Sherlock® Mycobacteria Identification System, which details the FDA's decision regarding its substantial equivalence to a predicate device and its intended use. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
§ 866.3370
Mycobacterium tuberculosis immunofluorescent reagents.(a)
Identification. Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyMycobacterium tuberculosis directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease.Mycobacterium tuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.(b)
Classification. Class I (general controls).