# DEN190031: NP Screen

- Pathway: De Novo (Direct)
- Applicant: Advance Sentry Corporation
- Decided: May 11, 2020 after 322 days
- Product code: OJY (Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers)
- Device class: 2
- Regulation: 21 CFR 866.3236
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
NP Screen is a semi-quantitative in vitro diagnostic test that uses real-time PCR to determine the level of Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) DNA in nasopharyngeal cellular specimens collected using the NP Screen Trans-Oral Nasopharyngeal Brush. The test is intended for use in conjunction with endoscopy and other clinical information to assess the likelihood that EBV-associated nasopharyngeal carcinoma (NPC) is present. The test is indicated for use in adults of Chinese descent with signs and symptoms of nasopharyngeal carcinoma. The NP Screen assay is a single-site assay performed at Primex Clinical Laboratories, Inc.

Source page: https://510kreport.com/device/DEN190031
Methodology: https://510kreport.com/methodology