NJO

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

Product code

NJO

Device name

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

Device class

Class 1

21 CFR

21 CFR 866.3370

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).