# K150412: Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Aug 28, 2015 after 191 days
- Product code: DAE (Complement C9, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- 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 CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals. The Optilite CH50 calibrator is intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CHS50 Reagent (product code NK095.0PT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals. The Optilite CH50 controls are intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.0PT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Source page: https://510kreport.com/device/K150412
Methodology: https://510kreport.com/methodology