# K962675: Sta - Liatest VWF Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Oct 25, 1996 after 108 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- 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 K861417 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861417: Assera-Plate VWF Kit, American Bioproducts Co. (1986) Summary page 1.

## Most influential descendants
- K220728: vWF Ag (2023), 0 descendants of its own

## Recalls of this device
- Jan 28, 2013 · Class II · Z-0951-2013: Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

## Indications for use
The STA®-Liatest® vWF test kit is intended for use with the STA® analyzer to perform quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific anti-vWF antibodies.

Source page: https://510kreport.com/device/K962675
Methodology: https://510kreport.com/methodology