Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5240](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5240) → DAK — Complement C1q, Antigen, Antiserum, Control # DAK · Complement C1q, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5240 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK ## Overview - **Product Code:** DAK - **Device Name:** Complement C1q, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5240](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5240) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K031563](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K031563.md) | BINDAZYME CLQ CIC EIA KIT | The Binding Site, Ltd. | Sep 10, 2003 | SESE | | [K032254](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K032254.md) | IBL C1Q-CIC CIA TEST | Ibl GmbH | Aug 29, 2003 | SESE | | [K012576](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K012576.md) | CIC-C1Q EIA | American Laboratory Products Co., Ltd. | Jan 29, 2002 | SESE | | [K973203](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K973203.md) | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES | Sangstat Medical Corp. | Sep 30, 1998 | SESE | | [K972873](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K972873.md) | IMMUSTRIP HAMA IGG | Immunomedics, Inc. | Mar 17, 1998 | SESE | | [K951968](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K951968.md) | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | May 30, 1995 | SESE | | [K914388](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K914388.md) | C1 RID KIT | The Binding Site, Ltd. | Oct 28, 1991 | SESE | | [K882829](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K882829.md) | CIRCULATING IMMUNE COMPLEXES CONTROLS | Cytotech, Inc. | Aug 4, 1988 | SESE | | [K860996](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K860996.md) | SANASSAY IC TEST | Scientific Sales Intl., Inc. | Mar 30, 1987 | SESE | | [K864312](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K864312.md) | IC MICROASSAY | Diamedix Corp. | Jan 9, 1987 | SESE | | [K862649](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K862649.md) | CYTOTECH CIC ENZYME IMMUNOASSAY | Cytotech, Inc. | Sep 4, 1986 | SESE | | [K861499](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K861499.md) | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | Jun 20, 1986 | SESE | | [K853697](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K853697.md) | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | Dec 16, 1985 | SESE | | [K851202](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K851202.md) | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | Gilford | Apr 29, 1985 | SESE | | [K844294](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K844294.md) | CORDIA IC | Cordis Corp. | Feb 4, 1985 | SESE | | [K833275](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K833275.md) | GMP CIQ ELISA TEST KIT | Gamma Medical Products, Inc. | Jun 22, 1984 | SESE | | [K833636](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K833636.md) | ORTHO* SERUM ELISA TEST SYSTEM | Ortho Diagnostic Systems, Inc. | Jun 13, 1984 | SESE | | [K841541](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K841541.md) | SERUM COMPLEMENT ACTIVITY TEST-SCAT | Collaborative Research, Inc. | Jun 1, 1984 | SESE | | [K823009](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K823009.md) | GAMMA CLQ | Gamma Medical Products, Inc. | Nov 5, 1982 | SESE | | [K821949](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK/K821949.md) | ORTHO* ALTERNATIVE PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | Aug 27, 1982 | SESE | ## Top Applicants - Ortho Diagnostic Systems, Inc. — 3 clearances - The Binding Site, Ltd. — 2 clearances - Icl Scientific — 2 clearances - Hyland Therapeutic Div., Travenol Laboratories — 2 clearances - Gamma Medical Products, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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