Product Code: JMO FDA class 1 21 CFR 862.1415

Ferrozine (Colorimetric) Iron Binding Capacity

Clinical Chemistry

This device is a colorimetric clinical chemistry reagent system using ferrozine to measure total iron-binding capacity (TIBC) in serum, providing an estimate of transferrin saturation used in the evaluation of iron deficiency, iron overload, and anemia of chronic disease. It is classified as FDA Class 1 and requires only general controls with no premarket submission. The product code is JMO, regulated under 21 CFR 862.1415, and assigned to the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JMO
Device Class: FDA class 1
Regulation Number: 862.1415
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K113438	ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT	Jun 01, 2012	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K061464	VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668	Jun 15, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K052867	VITROS CHEMISTRY PRODUCTS DTIBC REAGENT	Dec 23, 2005	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K041793	OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524	Jul 16, 2004	Substantially Equivalent	Olympus America, Inc.
K013102	WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002	Nov 13, 2001	Substantially Equivalent	Wiener Laboratories Saic
K012340	BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)	Oct 01, 2001	Substantially Equivalent	Bayer Corp.
K000781	DIRECT TIBC KIT	May 02, 2000	Substantially Equivalent	Reference Diagnostics, Inc.
K994115	TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE	Jan 28, 2000	Substantially Equivalent	Dade Behring, Inc.
K991666	TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02	Jun 30, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K991244	TOTAL IRON, MODELS FE 109-01, FE 109-02	May 25, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K990216	MAGNETIC TIBC KIT	Feb 16, 1999	Substantially Equivalent	Reference Diagnostics, Inc.
K982041	UIBC	Jul 30, 1998	Substantially Equivalent	Abbott Laboratories
K981654	TIBC	Jul 22, 1998	Substantially Equivalent	Abbott Laboratories
K981279	TIBC	May 20, 1998	Substantially Equivalent	Abbott Laboratories
K974604	RANDOX IRON	Jan 06, 1998	Substantially Equivalent	Randox Laboratories, Ltd.
K961587	IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25	Aug 27, 1996	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K963116	UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY	Aug 20, 1996	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K960485	SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS	May 10, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K955139	OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT	Feb 12, 1996	Substantially Equivalent	Olympus America, Inc.
K946354	DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE	May 08, 1995	Substantially Equivalent	Data Medical Associates, Inc.
K932517	IRON/UIBC REAGENT	Nov 09, 1993	Substantially Equivalent	Sigma Diagnostics, Inc.
K933329	KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT	Oct 22, 1993	Substantially Equivalent	King Diagnostics, Inc.
K931493	KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT	May 26, 1993	Substantially Equivalent	Eastman Kodak Company
K923569	PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT	Aug 26, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922784	SYNERMED UIBC REAGENT KIT	Jul 21, 1992	Substantially Equivalent	Synermed, Inc.
K912717	J&S UIBC REAGENTS	Sep 25, 1991	Substantially Equivalent	J.S. Medical Assoc.
K912716	J&S IRON REAGENTS	Sep 25, 1991	Substantially Equivalent	J.S. Medical Assoc.
K913922	ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01	Sep 19, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K912795	BIOTROL UIBC REAGENT	Aug 12, 1991	Substantially Equivalent	Biotrol, USA, Inc.
K904116	IRON 5 X CONC REAGENT	Sep 27, 1990	Substantially Equivalent	Trace Scientific , Ltd.
K901960	IRON REAGENTS PRODUCT CODES 7725 AND 7726	May 31, 1990	Substantially Equivalent	American Research Products Co.
K893662	J&S IRON SATURATING REAGENTS	Jul 20, 1989	Substantially Equivalent	J.S. Medical Assoc.
K883104	CHEM 1 UIBC (IRON BINDING CAPACITY TEST)	Oct 25, 1988	Substantially Equivalent	Technicon Instruments Corp.
K881761	UNSATURATED IRON BINDING CAPACITY	Jul 08, 1988	Substantially Equivalent	Data Medical Associates, Inc.
K880546	TOTAL IRON BINDING CAPACITY (TIBC)	Mar 24, 1988	Substantially Equivalent	Boehringer Mannheim Corp.
K874055	IRON REAGENT	Oct 28, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K871414	EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93	Apr 23, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863426	AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241	Sep 16, 1986	Substantially Equivalent	American Research Products Co.
K851930	TDX REA IRON/TIBC	May 24, 1985	Substantially Equivalent	Abbott Laboratories
K851395	SANDARE IRON-BINDING CAPACITY PROCEDURE	May 07, 1985	Substantially Equivalent	Sandare Chemical Co., Inc.
K850128	SYSTE MATE TIBC HEM NO. 67225	Feb 01, 1985	Substantially Equivalent	Em Diagnostic Systems, Inc.
K832759	TOTAL IRON-BINDING CAPACITY ACCESORY	Oct 14, 1983	Substantially Equivalent	Seragen Diagnostics, Inc.
K831202	SERUM UIBC-PTF-600 METHOD	May 25, 1983	Substantially Equivalent	American Monitor Corp.
K780094	IRON BINDING CAPACITY CHEMISTRY	Feb 13, 1978	Substantially Equivalent	Harleco
K771927	IRON SET, ITEM NO. 65008	Nov 14, 1977	Substantially Equivalent	Harleco
K770748	TEST, FERROZINE IRON & IRON BINDING	Jun 01, 1977	Substantially Equivalent	Hycel, Inc.