NJO · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3370
Classification
FDA Product Code
NJO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.3370
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.