# K020689: Sherlock Mycobacteria Identification System

- Pathway: 510(k) (Traditional)
- Applicant: Midi, Inc.
- Decided: Oct 31, 2002 after 241 days
- Product code: NJO (System, Mycolic Acid Analysis, Mycobacterium Tuberculosis)
- Device class: 1
- Regulation: 21 CFR 866.3370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MIDI Sherlock@Mycobacteria Identification 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 on the Agilent model 1100 HPLC, along with SherlockO 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 the MIDI Sherlock@Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.

Source page: https://510kreport.com/device/K020689
Methodology: https://510kreport.com/methodology