# K113349: Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls FO

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Jul 11, 2012 after 240 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
Human CH5O reagent pack for use on the SPA PLUS: These reagents are intended for the quantification of total classical complement activity (CH5O) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests. Human CH5O calibrator set for use on the SPA PLUS: The Human CH5O calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH5O reagent pack (product code: NK095.S) for the determination of total complement activity. Human CH5O controls for use on the SPA PLUS: The Human CH5O controls are intended for use in conjunction with the Binding Site Human CH5O reagent pack for use on the SPAPLUS (product code: NK095.S).

Source page: https://510kreport.com/device/K113349
Methodology: https://510kreport.com/methodology