NJO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

Device class

Class I (low risk)

Regulation

21 CFR 866.3370

Medical specialty

Microbiology

Flags

Third-party review eligible

FDA definition

A mycolic acids analysis 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 and 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 extraction and analysis of mycolic acids. Results should be interpreted in conjunction with other laboratory observations and procedures.

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