OJYClass II

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

21 CFR 866.3236 / Microbiology

OJY is the FDA product code for Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers, a class II device type, regulated under 21 CFR 866.3236. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2020-05-11, and no recalls.

Classification record

Product code: OJY
Device name: Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
FDA 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.
Regulation: 21 CFR 866.3236
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OJY

By decision year

1 clearance under product code OJY with a decision year between 2020 and 2020, 2020 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OJY by decision year
Year	Clearances
2020	1

Applicants with the most clearances

Product code OJY

Applicants holding the most 510(k) clearances under product code OJY
Applicant	Clearances
Advance Sentry Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code OJY

DEN190031Class IINP ScreenAdvance Sentry Corporation / cleared 2020-05-11

Recent recalls

Product code OJY

FDA records show no recalls under product code OJY.

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)