# K012576: Cic-C1Q Eia

- Pathway: 510(k) (Traditional)
- Applicant: American Laboratory Products Co., Ltd.
- Decided: Jan 29, 2002 after 173 days
- Product code: DAK (Complement C1q, 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 CIC-Clq EIA is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma of patients with various autoimmune and other CIC related diseases.

Source page: https://510kreport.com/device/K012576
Methodology: https://510kreport.com/methodology