# K992704: IL Test Von Willebrand Factor

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 1, 1999 after 81 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 K860371 (1986). 1 ancestor in all.
2 later devices descend 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)
- K860371: Asserachrom VWF Kit, American Bioproducts Co. (1986) Summary page 1.

## Most influential descendants
- K200033: HemosIL von Willebrand Factor Antigen (2020), 1 descendant of its own
- K223402: HemosIL von Willebrand Factor Antigen (2022), 0 descendants of its own

## Indications for use
IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).

Source page: https://510kreport.com/device/K992704
Methodology: https://510kreport.com/methodology