# K892859: The Stago Viii Deficient Plasma Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Jun 23, 1989 after 66 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102851: Nofact Viii (2011), 0 descendants of its own

## Recalls of this device
- Mar 4, 2020 · Class II · Z-1699-2020: A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely incr

Source page: https://510kreport.com/device/K892859
Methodology: https://510kreport.com/methodology