# DEN240035: ConcizuTrace™ ELISA

- Pathway: De Novo (Direct)
- Applicant: Randox Laboratories, Ltd.
- Decided: May 22, 2025 after 325 days
- Product code: SES (Non-Factor Replacement Product Test System)
- Device class: 2
- Regulation: 21 CFR 864.7298
- 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
For in vitro diagnostic use. The ConcizuTrace ELISA (enzyme linked immunosorbent assay) is intended for the quantitative measurement of concizumab concentration in human 3.2% citrated plasma samples from Hemophilia A and B patients after 4 weeks from the initiation of treatment with concizumab. The measurement of concizumab concentration is used for dose adjustment decision in accordance with the drug label. The ConcizuTrace ELISA is a manual assay performed by qualified healthcare professionals on the microplate reader qualified by Randox.

Source page: https://510kreport.com/device/DEN240035
Methodology: https://510kreport.com/methodology