Skip to content

Cytotech Cic Enzyme Immunoassay

by Cytotech, Inc. 510(k)

Active United States

510(k) K862649

Overview

The Cytotech Cic Enzyme Immunoassay is a device used for the detection of Complement C1q antigen, as indicated by its device name and classification under regulation number 866.5240. It is an immunoassay system designed to measure antigen-antibody reactions involving Complement C1q, with associated controls and antisera as part of its configuration.

The device received FDA 510(k) clearance (K862649) on September 4, 1986, and is classified as a Class II medical device. It is manufactured by Cytotech, Inc., located in San Diego, CA, and is intended for use in immunology testing environments. The assay is supplied as a kit containing antigen, antiserum, and control components for laboratory use.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862649 Date4 Sep 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-1496-2018 FDA Class II initiated 4 Apr 2017

    There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.

    • Terminated Z-1497-2018 FDA Class III initiated 3 Nov 2015

    A component of the kit was found to contain bacterial contamination.

Specification

510(k)

510(k) Number
FDA Product Code
DAK
Device Class
Class II
Regulation
21 CFR Part 866.5240
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Cytotech, Inc.

See all devices from Cytotech, Inc. →