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) → DBI — Complement C4, Antigen, Antiserum, Control # DBI · Complement C4, 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/DBI ## Overview - **Product Code:** DBI - **Device Name:** Complement C4, 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 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K100455](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K100455.md) | SPAPLUS ANALYZER | The Binding Site | Sep 3, 2010 | SESE | | [K012359](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K012359.md) | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | Roche Diagnostics Corp. | Nov 29, 2001 | SESE | | [K010325](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K010325.md) | WAKO AUTOKIT C4 | Wako Chemicals USA, Inc. | Jun 25, 2001 | SESE | | [K000468](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K000468.md) | RANDOX COMPLEMENT C4 | Randox Laboratories, Ltd. | Mar 27, 2000 | SESE | | [K994293](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K994293.md) | DIMENSION C4 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 1, 2000 | SESE | | [K981785](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K981785.md) | C4 MININEPH ANTISERUM | The Binding Site, Ltd. | Dec 20, 1999 | SESE | | [K993481](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K993481.md) | K-ASSAY C4 | Kamiya Biomedical Co. | Nov 29, 1999 | SESE | | [K983356](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K983356.md) | C4 | Abbott Laboratories | Nov 4, 1998 | SESE | | [K964300](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K964300.md) | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE | | [K964297](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K964297.md) | N-ASSAY TIA C4 TEST KIT | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE | | [K962582](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K962582.md) | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Oct 18, 1996 | SESE | | [K962198](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K962198.md) | QUANTEX C4 | Instrumentation Laboratory CO | Sep 26, 1996 | SESE | | [K920010](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K920010.md) | IL TEST COMPLEMENT 4 | Instrumentation Laboratory CO | Mar 13, 1992 | SESE | | [K911899](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K911899.md) | RAICHEM SPIA C4 REAGENT | Reagents Applications, Inc. | May 9, 1991 | SESE | | [K892129](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K892129.md) | EZ COMPLEMENT C4 | Diamedix Corp. | Apr 14, 1989 | SESE | | [K890564](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K890564.md) | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Atlantic Antibodies | Feb 17, 1989 | SESE | | [K882621](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K882621.md) | COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | Jul 8, 1988 | SESE | | [K872599](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K872599.md) | QM300 C4 ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jul 23, 1987 | SESE | | [K871023](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K871023.md) | PRECIMAT(R) C4 | Boehringer Mannheim Corp. | May 14, 1987 | SESE | | [K870931](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K870931.md) | TINA-QUANT(R) (A) C4 | Boehringer Mannheim Corp. | Mar 24, 1987 | SESE | ## Top Applicants - Technicon Instruments Corp. — 2 clearances - Kallestad Laboratories, Inc. — 2 clearances - Instrumentation Laboratory CO — 2 clearances - G.D. Searle and Co. — 2 clearances - Dako Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com