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) → JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin # JMG · Radioimmunoassay (Two-Site Solid Phase), Ferritin _Immunology · 21 CFR 866.5340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG ## Overview - **Product Code:** JMG - **Device Name:** Radioimmunoassay (Two-Site Solid Phase), Ferritin - **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 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K234052](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K234052.md) | Access Ferritin | Beckman Coulter, Inc. | Mar 20, 2024 | SESE | | [K052082](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K052082.md) | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | Aug 19, 2005 | SESE | | [K964282](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K964282.md) | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | Jul 30, 1997 | SESE | | [K971833](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K971833.md) | ELECSYS FERRITIN | Boehringer Mannheim Corp. | Jun 2, 1997 | SESE | | [K963498](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K963498.md) | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | Jan 24, 1997 | SESE | | [K950393](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K950393.md) | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | May 16, 1995 | SESE | | [K926221](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K926221.md) | ACCESS FERRITIN ASSAY | Bio-Rad Laboratories, Inc. | Jan 13, 1993 | SESE | | [K925848](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K925848.md) | IMMULITE FERRITIN | Diagnostic Products Corp. | Jan 13, 1993 | SESE | | [K920829](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K920829.md) | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | Jun 19, 1992 | SESE | | [K920318](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K920318.md) | CEDIA FERRITIN ASSAY | Microgenics Corp. | Jun 4, 1992 | SESE | | [K902997](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K902997.md) | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | Aug 2, 1990 | SESE | | [K890697](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K890697.md) | RIA-GNOST FERRITIN | Cambridge Medical Technology | Mar 16, 1989 | SESE | | [K881138](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K881138.md) | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | Apr 21, 1988 | SESE | | [K873730](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K873730.md) | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Nov 4, 1987 | SESE | | [K872955](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K872955.md) | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | Aug 21, 1987 | SESE | | [K840460](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K840460.md) | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | Mar 30, 1984 | SESE | | [K810799](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K810799.md) | QUANTIMUNE FERRITIN IRMA | Bio-Rad | Apr 3, 1981 | SESE | | [K792588](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K792588.md) | TERRITIN RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 11, 1980 | SESE | | [K791096](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K791096.md) | RADIOIMMUNOASSAY TEST SYSTEM | Corning Medical & Scientific | Aug 3, 1979 | SESE | | [K782157](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG/K782157.md) | IRMA TEST, NORDICLAB FERRITIN | Nordiclab Intl. | Jan 17, 1979 | SESE | ## Top Applicants - Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances - Beckman Coulter, Inc. — 2 clearances - Boehringer Mannheim Corp. — 2 clearances - Corning Medical & Scientific — 2 clearances - Diagnostic Products Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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