FDA product code OJY: Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

OJY is the FDA product code for device to detect or measure nucleic acid from viruses associated with head and neck cancers. It is a Class II device, regulated under 21 CFR 866.3236 and reviewed by the Microbiology panel. Devices under OJY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

A device to detect or measure nucleic acid from viruses associated with head and neck cancers is an in vitro diagnostic test for prescription use in the detection of viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer. The test result is intended to be used in conjunction with other clinical information to aid in assessing the clinical status of virus-associated head and neck cancers and/or the likelihood that head and neck cancer is present.

Classification

Recalls for OJY devices

openFDA lists no recalls for product code OJY.

Frequently asked questions

What is FDA product code OJY?

OJY is the FDA product code for device to detect or measure nucleic acid from viruses associated with head and neck cancers. It is a Class II device, regulated under 21 CFR 866.3236 and reviewed by the Microbiology panel.

What device class is OJY?

Class II, regulation 21 CFR 866.3236. Typical premarket route: 510(k).

Next steps

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