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/productcode/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](/device/K234052.md) | Access Ferritin | Beckman Coulter, Inc. | Mar 20, 2024 | SESE |
| [K052082](/device/K052082.md) | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | Aug 19, 2005 | SESE |
| [K964282](/device/K964282.md) | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | Jul 30, 1997 | SESE |
| [K971833](/device/K971833.md) | ELECSYS FERRITIN | Boehringer Mannheim Corp. | Jun 2, 1997 | SESE |
| [K963498](/device/K963498.md) | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | Jan 24, 1997 | SESE |
| [K950393](/device/K950393.md) | ACE(TM) CEDIA(R) FERRITIN  ASSAY | Schiapparelli Biosystems, Inc. | May 16, 1995 | SESE |
| [K926221](/device/K926221.md) | ACCESS FERRITIN ASSAY | Bio-Rad Laboratories, Inc. | Jan 13, 1993 | SESE |
| [K925848](/device/K925848.md) | IMMULITE FERRITIN | Diagnostic Products Corp. | Jan 13, 1993 | SESE |
| [K920829](/device/K920829.md) | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | Jun 19, 1992 | SESE |
| [K920318](/device/K920318.md) | CEDIA FERRITIN ASSAY | Microgenics Corp. | Jun 4, 1992 | SESE |
| [K902997](/device/K902997.md) | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | Aug 2, 1990 | SESE |
| [K890697](/device/K890697.md) | RIA-GNOST FERRITIN | Cambridge Medical Technology | Mar 16, 1989 | SESE |
| [K881138](/device/K881138.md) | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | Apr 21, 1988 | SESE |
| [K873730](/device/K873730.md) | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Nov 4, 1987 | SESE |
| [K872955](/device/K872955.md) | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | Aug 21, 1987 | SESE |
| [K840460](/device/K840460.md) | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | Mar 30, 1984 | SESE |
| [K810799](/device/K810799.md) | QUANTIMUNE FERRITIN IRMA | Bio-Rad | Apr 3, 1981 | SESE |
| [K792588](/device/K792588.md) | TERRITIN RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 11, 1980 | SESE |
| [K791096](/device/K791096.md) | RADIOIMMUNOASSAY TEST SYSTEM | Corning Medical & Scientific | Aug 3, 1979 | SESE |
| [K782157](/device/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/productcode/JMG](https://fda.innolitics.com/productcode/JMG)

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