# K122304: Human C1 Inactivator Kit for Use on Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Apr 15, 2013 after 257 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
This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K122304
Methodology: https://510kreport.com/methodology