# K200033: HemosIL von Willebrand Factor Antigen

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 19, 2020 after 225 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: 2 generations back to K860371 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992704: IL Test Von Willebrand Factor, Instrumentation Laboratory CO (1999) Summary page 4.

## Most influential descendants
- K223402: HemosIL von Willebrand Factor Antigen (2022), 0 descendants of its own

## Indications for use
Automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma on IL Coagulation Systems.

Source page: https://510kreport.com/device/K200033
Methodology: https://510kreport.com/methodology