NJOClass I

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

21 CFR 866.3370 / Microbiology

NJO is the FDA product code for System, Mycolic Acid Analysis, Mycobacterium Tuberculosis, a class I device type, regulated under 21 CFR 866.3370. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2002-10-31, and no recalls.

Classification record

Product code: NJO
Device name: System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
FDA 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: 21 CFR 866.3370
Device class: Class I
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code NJO

By decision year

1 clearance under product code NJO with a decision year between 2002 and 2002, 2002 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NJO by decision year
Year	Clearances
2002	1

Applicants with the most clearances

Product code NJO

Applicants holding the most 510(k) clearances under product code NJO
Applicant	Clearances
Midi, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NJO.

Recent clearances

Product code NJO

K020689Class ISherlock Mycobacteria Identification SystemMidi, Inc. / cleared 2002-10-31

Recent recalls

Product code NJO

FDA records show no recalls under product code NJO.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)