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U.S. Department of Health and Human Services

Product Classification

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Device system, mycolic acid analysis, mycobacterium tuberculosis
Regulation Description Mycobacterium tuberculosis immunofluorescent reagents.
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.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNJO
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3370
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons