# K935254: Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Sep 19, 1994 after 322 days
- Product code: GIZ (Plasma, Control, Normal)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K102552: Hemosil LA Positive Control (2011), 0 descendants of its own
- K083878: Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K935254
Methodology: https://510kreport.com/methodology