# K181473: DENV Detect NS1 ELISA

- Pathway: 510(k) (Traditional)
- Applicant: InBios International, Inc.
- Decided: Aug 27, 2018 after 84 days
- Product code: QCU (Dengue Virus Antigen Assay)
- Device class: 2
- Regulation: 21 CFR 866.3945
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DENV DetectTM NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 – day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision. This assay is not FDA cleared or approved for testing blood or plasma donors.

Source page: https://510kreport.com/device/K181473
Methodology: https://510kreport.com/methodology