# K983107: VFE

- Pathway: 510(k) (Traditional)
- Applicant: Ramco Laboratories, Inc.
- Decided: Oct 22, 1998 after 48 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 K861159 (1986). 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)
- K861159: Spectro VWF, Ramco Laboratories, Inc. (1986) Summary page 1.

## Indications for use
The VFE assay is an in vitro enzyme immunoassay for quantifying the concentration of von Willebrand Factor Antigen in human plasma to aid in differentiating patients with von Willebrand disease from those with Classical Hemophilia A.

Source page: https://510kreport.com/device/K983107
Methodology: https://510kreport.com/methodology