FDA product code NJO: System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
NJO is the FDA product code for system, mycolic acid analysis, mycobacterium tuberculosis. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under NJO. The average 510(k) review took 241 days (median 241).
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Mycolic Acid Analysis, Mycobacterium Tuberculosis |
| Device class | Class I |
| Regulation | 21 CFR 866.3370 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NJO clearance
Top NJO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midi, Inc. | 1 | 2002-10-31 |
Most recent NJO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020689 | Midi, Inc. | SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM | 2002-10-31 | 241 |
Recalls for NJO devices
openFDA lists no recalls for product code NJO.
Frequently asked questions
What is FDA product code NJO?
NJO is the FDA product code for system, mycolic acid analysis, mycobacterium tuberculosis. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel.
What device class is NJO?
Class I, regulation 21 CFR 866.3370. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJO?
Across 1 cleared submissions the average was 241 days from receipt to decision (median 241).
Which companies have the most NJO clearances?
Midi, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJO
- Run a recall and safety report across every NJO manufacturer
- Watch product code NJO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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