# K032139: Reaads Von Willebrand Factor Activity Test Kit, Model 10826

- Pathway: 510(k) (Traditional)
- Applicant: Corgenix, Inc.
- Decided: Apr 5, 2004 after 269 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000398 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000398: Shield Von Willebrand Factor Activity Elisa, Model FVWF 200, Shield Diagnostics, Ltd. (2000) Summary page 1.

## Indications for use
The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma. The REAADS von Willebrand Factor Activity Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K032139
Methodology: https://510kreport.com/methodology