510(k) DEN190031
DEN190031 is an FDA 510(k) premarket notification submitted by Advance Sentry Corporation for the device "NP Screen". The FDA issued a decision of De Novo Granted on May 11, 2020. The device falls under product code OJY (Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers), a Class II device regulated under 21 CFR 866.3236.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 11, 2020
- Date Received
- June 24, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
- Device Class
- Class II
- Regulation Number
- 866.3236
- Review Panel
- MI
- Submission Type
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.