# K031563: Bindazyme CLQ Cic Eia Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Sep 10, 2003 after 114 days
- Product code: DAK (Complement C1q, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Oct 28, 2009 · Not classified · Z-1942-2010: The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as

## Indications for use
This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, present in human serum. It is intended for the determination of CIC in serum of patients with various autoimmune and other CIC-related disease, and is used in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K031563
Methodology: https://510kreport.com/methodology