# K980885: Shield Activated Factor Xii (Elisa) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Shield Diagnostics, Ltd.
- Decided: Aug 21, 1998 after 165 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Shield Activated Factor X11 (FX11a) assay is a semi-quantitative direct enzyme immunoassay for the detection, in human citrated plasma, of activated factor X11 (¢—X11a and B— X11a). The test may be used as an index of activation of the contact (intrinsic) system of coagulation

Source page: https://510kreport.com/device/K980885
Methodology: https://510kreport.com/methodology