# K965024: N-Assay Tia C1-Inactivator Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Jul 14, 1997 after 209 days
- Product code: DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5250
- 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 N-Assay TIA C1 Inactivator Test Kit is intended to be used for the quantification of C1 Inactivator in human plasma. C1 Inactivator is measured by immunoturbidimetric assay. Measurement of Complement 1 Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.

Source page: https://510kreport.com/device/K965024
Methodology: https://510kreport.com/methodology