Product Code: DDG FDA class 2 21 CFR 866.5880

Transferrin, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring transferrin, the major iron-binding and iron-transporting protein in human plasma, using antigen, antiserum, and control components for immunoassay-based assessment of iron transport capacity and iron status. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDG, regulated under 21 CFR 866.5880, within the Immunology specialty.

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Basic Information

Product Code: DDG
Device Class: FDA class 2
Regulation Number: 866.5880
Medical Specialty: Immunology
Review Panel: IM
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 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240987	Access sTfR	Jul 03, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K190495	Transferrin	Mar 16, 2020	Substantially Equivalent	Biosystems S.A.
K182095	Tina-quant Transferrin ver.2 (urine application)	Nov 05, 2018	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K120236	TRANSFERRIN KIT FOR USE ON THE SPAPLUS	Feb 13, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K080634	ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495	Aug 11, 2008	Substantially Equivalent	Beckman Coulter, Inc.
K081299	DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA	Aug 08, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K063086	TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS	Aug 08, 2007	Substantially Equivalent	Thermo Electron OY
K063766	TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C	Apr 23, 2007	Substantially Equivalent	Good Biotech Corp.
K063663	DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H	Mar 21, 2007	Substantially Equivalent	Dade Behring, Inc.
K063322	DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H	Jan 24, 2007	Substantially Equivalent	Dade Behring, Inc.
K053075	N ANTISERA TO HUMAN TRANSFERRIN	Mar 16, 2006	Substantially Equivalent	Dade Behring, Inc.
K042477	VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN	Nov 19, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K012393	TINA-QUANT TRANSFERRIN VER.2	Sep 19, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K012371	TINA-QUANT TRANSFERRIN VER.2	Sep 19, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K011662	MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL	Jul 30, 2001	Substantially Equivalent	The Binding Site, Ltd.
K003064	TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323	May 01, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K002585	RANDOX TRANSFERRIN	Feb 05, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K994294	DIMENSION TRNF FLEX REAGENT CARTRIDGE	Feb 04, 2000	Substantially Equivalent	Dade Behring, Inc.
K993537	K-ASSAY TRANSFERRIN	Nov 30, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K993162	WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR	Nov 12, 1999	Substantially Equivalent	Wako Chemicals USA, Inc.
K991157	N LATEX STFR REAGENT	Aug 02, 1999	Substantially Equivalent	Dade Behring, Inc.
K983880	TRANSFERRIN SPQ III ANTIBODY REAGENT SET	Dec 18, 1998	Substantially Equivalent	DiaSorin, Inc.
K983167	TRF	Nov 04, 1998	Substantially Equivalent	Abbott Laboratories
K972840	N ANTISERUM TO HUMAN TRANSFERRIN	Oct 17, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K971958	SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT	Aug 20, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K964295	N-ASSAY TIA TRANSFERRIN TEST KIT	Jun 16, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K963976	IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT	Mar 19, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K963427	IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT	Oct 07, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K933589	BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY	Nov 03, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K926272	BECKMAN TRANSFERRIN KIT	Oct 07, 1993	Substantially Equivalent	Beckman Instruments, Inc.
K914993	IL TEST(TM) TRANSFERRIN (TRF)	Jan 17, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K914390	TRANSFERRIN RID KIT	Dec 09, 1991	Substantially Equivalent	The Binding Site, Ltd.
K900875	RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT	Mar 06, 1990	Substantially Equivalent	Reagents Applications, Inc.
K890563	SPQ(TM) ANTIBODY REAGENT SET II FOR TRF	Mar 03, 1989	Substantially Equivalent	Atlantic Antibodies
K884075	IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN	Oct 19, 1988	Substantially Equivalent	Orion Diagnostica, Inc.
K873867	TRANSFERRIN	Oct 13, 1987	Substantially Equivalent	Unipath , Ltd.
K873789	QM300 TRANSFERRIN ANTIBODY PACK	Oct 07, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K871896	TINA-QUANT [A] TRANSFERRIN	Jun 15, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K871022	PRECIMAT(R) TRANSFERRIN	May 14, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K854416	TDX TRANSFERRIN DIAGNOSTIC KIT	Feb 21, 1986	Substantially Equivalent	Abbott Laboratories
K851287	RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN	May 24, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K850589	SPQ TEST SYSTEM FOR TRANSFERRIN	Mar 05, 1985	Substantially Equivalent	Applications Lab
K830911	RADIAL IMMUNODIFFUSION PLATES	Jun 10, 1983	Substantially Equivalent	Biocell Laboratories, Inc.
K813288	NEIA TRANSFERRIN ENZYMEIMMUNOASSAY	Dec 17, 1981	Substantially Equivalent	New England Immunology Assoc.
K812492	IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K811613	72 DETERMIN. SIZE RADIAL IMMUNOD. TEST	Aug 12, 1981	Substantially Equivalent	Kent Laboratories, Inc.
K801434	J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS	Jul 08, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K772253	TRANSFERRIN NEPHELOMETRIC ASSAY	Dec 22, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.