# K040843: Hemosil Von Willebrand Activity

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 30, 2004 after 29 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Apr 11, 2012 · Not classified · Z-1519-2012: Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.

## Indications for use
HemoslL von Willebrand Factor Activity is an in vitro diagnostic automated latex enhanced immunoassay intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems by immunoturbidity.

Source page: https://510kreport.com/device/K040843
Methodology: https://510kreport.com/methodology