NJO — System, Mycolic Acid Analysis, Mycobacterium Tuberculosis Class I
FDA product code NJO covers "System, Mycolic Acid Analysis, Mycobacterium Tuberculosis", a Class I medical device regulated under 21 CFR 866.3370. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NJO
- Device Class
- Class I
- Regulation Number
- 866.3370
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K020689 | midi | SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM | October 31, 2002 |