Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5340](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5340) → DBF — Ferritin, Antigen, Antiserum, Control # DBF · Ferritin, Antigen, Antiserum, Control _Immunology · 21 CFR 866.5340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF ## Overview - **Product Code:** DBF - **Device Name:** Ferritin, Antigen, Antiserum, Control - **Regulation:** [21 CFR 866.5340](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5340) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 87) Showing 20 most recent of 87 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K193650](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K193650.md) | LIAISON Ferritin | DiaSorin, Inc. | Sep 14, 2021 | SESE | | [K191562](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K191562.md) | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | HORIBA ABX SAS | Mar 6, 2020 | SESE | | [K171642](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K171642.md) | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | Aug 31, 2017 | SESE | | [K133083](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K133083.md) | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET | Diazyme Laboratories | Jun 24, 2014 | SESE | | [K121232](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K121232.md) | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | Kamiya Biomedical Company | May 24, 2012 | SESE | | [K110736](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K110736.md) | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | Siemens Healthcare Diagnostics, Inc. | Aug 17, 2011 | SESE | | [K100538](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K100538.md) | TINA-QUANT FERRITIN GEN. 4 | Roche Diagnostics | Jun 22, 2010 | SESE | | [K092505](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K092505.md) | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | Beckman Coulter, Inc. | Dec 11, 2009 | SESE | | [K062746](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K062746.md) | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | Nov 20, 2006 | SESE | | [K053211](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K053211.md) | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | Mar 13, 2006 | SESE | | [K052617](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K052617.md) | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | Good Biotech Corp. | Feb 23, 2006 | SESE | | [K050944](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K050944.md) | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | Dec 23, 2005 | SESE | | [K040879](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K040879.md) | QUANTEX FERRITIN | Instrumentation Laboratory CO | May 10, 2004 | SESE | | [K031650](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K031650.md) | FERRITIN GENERATION 2 | Roche Diagnostics Corp. | Jul 17, 2003 | SESE | | [K030124](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K030124.md) | OLYMPUS FERRITIN REAGENT | Olympus America, Inc. | Feb 6, 2003 | SESE | | [K014293](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K014293.md) | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | Feb 19, 2002 | SESE | | [K000662](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K000662.md) | RANDOX FERRITIN | Randox Laboratories, Ltd. | Apr 3, 2000 | SESE | | [K993273](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K993273.md) | N LATEX FERRITIN | Dade Behring, Inc. | Nov 23, 1999 | SESE | | [K992517](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K992517.md) | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Biocheck, Inc. | Sep 24, 1999 | SESE | | [K992157](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K992157.md) | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Chiron Diagnostics Corp. | Aug 5, 1999 | SESE | ## Top Applicants - Amersham Corp. — 6 clearances - Hybritech, Inc. — 3 clearances - Diagnostic Products Corp. — 3 clearances - Abbott Laboratories — 3 clearances - Siemens Healthcare Diagnostics, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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