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) → CZW — Complement C3, Antigen, Antiserum, Control # CZW · Complement C3, 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/CZW ## Overview - **Product Code:** CZW - **Device Name:** Complement C3, 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 44) Showing 20 most recent of 44 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K100179](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K100179.md) | SPAPLUS | The Binding Site Group , Ltd. | Aug 13, 2010 | SESE | | [K063150](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K063150.md) | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | Thermo Electron OY | Mar 19, 2007 | SESE | | [K061852](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K061852.md) | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | Sep 22, 2006 | SESE | | [K050665](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K050665.md) | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | Dade Behring, Inc. | May 2, 2005 | SESE | | [K042494](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K042494.md) | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | Ortho-Clinical Diagnostics | Oct 19, 2004 | SESE | | [K032796](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K032796.md) | IBL C3D-CIC EIA TEST | Ibl GmbH | Jan 13, 2004 | SESE | | [K032035](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K032035.md) | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI | Beckman Coulter, Inc. | Aug 7, 2003 | SESE | | [K012361](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K012361.md) | TINA-QUANT COMPLEMENT C3C TEST SYSTEM | Roche Diagnostics Corp. | Nov 29, 2001 | SESE | | [K010326](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K010326.md) | WAKO AUTOKIT C3 | Wako Chemicals USA, Inc. | Jun 25, 2001 | SESE | | [K000469](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K000469.md) | RANDOX COMPLEMENT C3 | Randox Laboratories, Ltd. | Mar 27, 2000 | SESE | | [K994296](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K994296.md) | DIMENSION C3 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 1, 2000 | SESE | | [K981783](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K981783.md) | C3 MININEPH ANTISERUM | The Binding Site, Ltd. | Dec 20, 1999 | SESE | | [K993437](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K993437.md) | K-ASSAY C3 | Kamiya Biomedical Co. | Nov 24, 1999 | SESE | | [K991907](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K991907.md) | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | Nov 9, 1999 | SESE | | [K983441](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K983441.md) | C3 | Abbott Laboratories | Nov 4, 1998 | SESE | | [K964298](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K964298.md) | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE | | [K964842](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K964842.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | Beckman Instruments, Inc. | Jun 11, 1997 | SESE | | [K962409](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K962409.md) | OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT | Olympus America, Inc. | Oct 18, 1996 | SESE | | [K962199](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K962199.md) | QUANTEX C3 | Instrumentation Laboratory CO | Sep 25, 1996 | SESE | | [K955857](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K955857.md) | N PROTEIN STANDARS SY | Behring Diagnostics, Inc. | Feb 21, 1996 | SESE | ## Top Applicants - Dako Corp. — 3 clearances - Dade Behring, Inc. — 3 clearances - The Binding Site, Ltd. — 2 clearances - Instrumentation Laboratory CO — 2 clearances - Diamedix Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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