FDA product code OJN: Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

OJN is the FDA product code for mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test. It is a Class III device, reviewed by the Microbiology panel. Devices under OJN reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 5 recalls for OJN devices, 3 initiated in the last five years.

Definition

For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.

Classification

Recalls for OJN devices

5 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-07-07.

Frequently asked questions

What is FDA product code OJN?

OJN is the FDA product code for mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test. It is a Class III device, reviewed by the Microbiology panel.

What device class is OJN?

Class III. Typical premarket route: PMA.

Have OJN devices been recalled?

Yes: 5 product recalls across 2 recall events; the most recent began 2022-07-07.

Next steps

• Run an FDA pathway report with predicate devices for product code OJN
• Run a recall and safety report across every OJN manufacturer
• Watch product code OJN 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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