# K141100: Optilite C1 Inactivator Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Jul 18, 2014 after 80 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 Optilite C1 Inactivator Kit is intended for the quantitative in vitro measurement of human ClI Inactivator in human serum using the Binding Site Optilite analyser. Measurement of ClI inactivator levels in serum is an aid in the diagnosis of hereditary angioedemna (RAE) in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K141100
Methodology: https://510kreport.com/methodology