Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5210](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5210) → DDB — Ceruloplasmin, Antigen, Antiserum, Control # DDB · Ceruloplasmin, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5210 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB ## Overview - **Product Code:** DDB - **Device Name:** Ceruloplasmin, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5210](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5210) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) ## Identification A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K161508](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K161508.md) | Ceruloplasmin | Beckman Coulter Ireland, Inc. | Jan 9, 2017 | SESE | | [K122965](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K122965.md) | HUMAN CAERULOPLASMIN KIT | The Binding Site Group , Ltd. | Jun 3, 2013 | SESE | | [K053074](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K053074.md) | N ANTISERA TO HUMAN CERULOPLASMIN | Dade Behring, Inc. | Mar 16, 2006 | SESE | | [K964762](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K964762.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | Beckman Instruments, Inc. | Apr 25, 1997 | SESE | | [K913668](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K913668.md) | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | Dec 20, 1991 | SESE | | [K895377](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K895377.md) | QM300 CERULOPLASMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Sep 21, 1989 | SESE | | [K860138](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K860138.md) | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM | Sigma Diagnostics, Inc. | Mar 28, 1986 | SESE | | [K850682](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K850682.md) | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | Kent Laboratories, Inc. | Nov 25, 1985 | SESE | | [K852247](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K852247.md) | LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) | Behring Diagnostics, Inc. | Jul 10, 1985 | SESE | | [K851283](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K851283.md) | RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN | Cooper Biomedical, Inc. | May 23, 1985 | SESE | | [K823107](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K823107.md) | QUANTIMETRIC 2 CERULOPLASMIN ASSAY | Kallestad Laboratories, Inc. | Nov 16, 1982 | SESE | | [K812486](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K812486.md) | IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL | Dako Corp. | Sep 23, 1981 | SESE | | [K801661](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K801661.md) | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | J.T. Baker Chemical Co. | Sep 16, 1980 | SESE | | [K791339](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K791339.md) | HUMAN CERULOPLASMIN | Beckman Instruments, Inc. | Aug 16, 1979 | SESE | | [K790714](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K790714.md) | ANTISERUM TO HUMAN CERULOPLASMIN | Kent Laboratories, Inc. | Aug 16, 1979 | SESE | | [K790712](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K790712.md) | ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI | Kent Laboratories, Inc. | Aug 16, 1979 | SESE | | [K781024](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K781024.md) | CERUOPLASMIN SERUM ANTI-HUMAN | Icl Scientific | Aug 14, 1978 | SESE | | [K772255](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K772255.md) | CERULOPLASMIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | Jan 5, 1978 | SESE | | [K771795](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K771795.md) | LAS-R CERULOPLASMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | Nov 14, 1977 | SESE | ## Top Applicants - Kent Laboratories, Inc. — 3 clearances - Beckman Instruments, Inc. — 2 clearances - Kallestad Laboratories, Inc. — 2 clearances - Beckman Coulter Ireland, Inc. — 1 clearance - Behring Diagnostics, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB) **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