510(k) K020689
K020689 is an FDA 510(k) premarket notification submitted by Midi, Inc. for the device "SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 2002. The device falls under product code NJO (System, Mycolic Acid Analysis, Mycobacterium Tuberculosis), a Class I device regulated under 21 CFR 866.3370. Midi, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2002
- Date Received
- March 4, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
- Device Class
- Class I
- Regulation Number
- 866.3370
- Review Panel
- MI
- Submission Type
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.