Product Code: JMG FDA class 2 21 CFR 866.5340

Radioimmunoassay (Two-Site Solid Phase), Ferritin

Immunology

This device is a two-site solid-phase radioimmunoassay system used to measure serum ferritin concentrations, providing an indicator of total body iron stores used in diagnosing iron deficiency anemia, iron overload disorders such as hemochromatosis, and inflammatory states that elevate ferritin as an acute-phase reactant. It is classified as FDA Class 2, requiring 510(k) premarket notification, under 21 CFR 866.5340, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: JMG
Device Class: FDA class 2
Regulation Number: 866.5340
Medical Specialty: Immunology
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K234052	Access Ferritin	Mar 20, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K052082	FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020	Aug 19, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K964282	TINA-QUANT FERRITIN ASSAY	Jul 30, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K971833	ELECSYS FERRITIN	Jun 02, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K963498	FERR FLEX REAGENT CARTRIDGE	Jan 24, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K950393	ACE(TM) CEDIA(R) FERRITIN ASSAY	May 16, 1995	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K926221	ACCESS FERRITIN ASSAY	Jan 13, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K925848	IMMULITE FERRITIN	Jan 13, 1993	Substantially Equivalent	Diagnostic Products Corp.
K920829	COBAS CORE FERRITIN EIA	Jun 19, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K920318	CEDIA FERRITIN ASSAY	Jun 04, 1992	Substantially Equivalent	Microgenics Corp.
K902997	MILENIA (TM) FERRITIN	Aug 02, 1990	Substantially Equivalent	Diagnostic Products Corp.
K890697	RIA-GNOST FERRITIN	Mar 16, 1989	Substantially Equivalent	Cambridge Medical Technology
K881138	CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.	Apr 21, 1988	Substantially Equivalent	Baxter Healthcare Corp
K873730	MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT	Nov 04, 1987	Substantially Equivalent	Medix Biotech, Inc.
K872955	DELFIA(TM) FERRITIN KIT	Aug 21, 1987	Substantially Equivalent	Lkb Instruments, Inc.
K840460	CORNINGS MAGIC FERRITIN RADIOIMMUNO-	Mar 30, 1984	Substantially Equivalent	Corning Medical & Scientific
K810799	QUANTIMUNE FERRITIN IRMA	Apr 03, 1981	Substantially Equivalent	Bio-Rad
K792588	TERRITIN RIA KIT	Jan 11, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K791096	RADIOIMMUNOASSAY TEST SYSTEM	Aug 03, 1979	Substantially Equivalent	Corning Medical & Scientific
K782157	IRMA TEST, NORDICLAB FERRITIN	Jan 17, 1979	Substantially Equivalent	Nordiclab Intl.
K781946	RIA KIT, FERRITIN SOLID PHASE	Jan 10, 1979	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K781888	ASSAY SYSTEM, FERRITIN I KIT	Jan 10, 1979	Substantially Equivalent	New England Nuclear
K781844	FERRITIN KIT	Jan 10, 1979	Substantially Equivalent	Ria Products, Inc.
K781527	RIA SYSTEM FOR HUMAN FE-RITIN	Oct 03, 1978	Substantially Equivalent	Calbiochem-Behring Corp.