# DEN210056: Procise IFX

- Pathway: De Novo (Direct)
- Applicant: Procisedx, Inc.
- Decided: Sep 29, 2023 after 660 days
- Product code: QXT (Infliximab Test System)
- Device class: 2
- Regulation: 21 CFR 862.3115
- 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
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.

Source page: https://510kreport.com/device/DEN210056
Methodology: https://510kreport.com/methodology