# DEN220023: Procise ADL

- Pathway: De Novo (Direct)
- Applicant: Procisedx, Inc.
- Decided: Sep 29, 2023 after 543 days
- Product code: QYD (Adalimumab Assay)
- 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 ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.

Source page: https://510kreport.com/device/DEN220023
Methodology: https://510kreport.com/methodology